MEDICAL DEVICES RECALL LISTINGS: 2011docshare01.docshare.tips/files/8606/86062548.pdf · A) S/5 Aespire 7900 SmartVent Anesthesia System B) S/5 Aespire Anesthesia Machine C) GE Darex-Ohmeda

MEDICAL DEVICES RECALL LISTINGS: 2011

Trade Name ManufacturerRecall Posting

DateRecall Start Date Recall Number

Hazard

ClassificationModel or Catalog # Lot or Serial # Reason for Recall

A) S/5 Aespire 7900 SmartVent Anesthesia System

B) S/5 Aespire Anesthesia Machine

C) GE Darex-Ohmeda Avance Anesthesia System

Datex-Ohmeda, Inc. DBA GE Healthcare 2011-01-10 2010-05-07 54484 Type II A) 1009-9012-000

B) 1009-9000-000

C) 1009-9002-000

A) >10 Numbers, Contact Manufacturer

B) AMXN00185, AMXN00499, AMXM01179,

AMXL00152, AMXL00260, AMXL02044,

AMXL00153, AMXM00411, AMXM00843,

AMXM00845

C) >10 Numbers, Contact Manufacturer

Potential for O2 flush button to become impeded by the work surface & to stick in the open

or partially open position, resulting in flow of O2 into the breathing system causing dilution

of anaesthetic agent.

A) Synchron LX20 System Analyzer - Class 2

B) Unicel DXC 600

C) Unicel DXC 800

D) Unicel DXC 600I Synchron Access Clinical Analyzer

E) Unicel DXC 880I Synchron Access Clinical Analyzer

F) Synchron LXI 725

G) Synchron LX20 Pro

H) Unicel DXC 660I Synchron Access Clinical Analyzer

I) Unicel DXC 680I Synchron Access Clinical Analyzer

J) Unicel DXC 860I Synchron Access Clinical Analyzer

Beckman Coulter, Inc. 2011-01-10 2010-10-18 58420 Type II A) 466002

B) 4764

C) 4764

D) 4767

E) 4768

F) 476501

G) 476100

H) 4771

I) 4772

J) 4773

A) All lots

B) All lots

C) All lots

D) All lots

E) All lots

F) All lots

G) All lots

H) All lots

I) All lots

J) All lots

For user-defined chemistries (UDRS) in the Synchron LX and Unicel DXC Clinical Systems,

the polychrome correction is not automatically updated when wavelengths are modified.

Discovery MR450 1.5T MR System - Main Unit GE Medical Systems LLC 2011-01-10 2010-11-17 58680 Type II Discovery MR450 1.5T MR System S/N 00000000863M21 Gradient cooling manifolds used on affected system may contain electrically conductive

hoses, which become live when gradient system is powered on. Potential for electric shock.

Access System - Total BHCG Assay Beckman Coulter, Inc. 2011-01-10 2010-11-08 59044 Type II 33500, 33505 All lots Beckman Coulter has confirmed that non-reproducible falsely elevated test results may

occur when using the Access Total BHCG Assay.

Classic Style Fine Tip Pen with Ruler & Labels Cardinal Health 2011-01-10 2010-11-16 59306 Type II 250FPRL 2015-07-08 The recall has been initiated due to incorrect expiration dating. The product has a two year

shelf life and not five years as indicated on the labelling. This error doesn't impact the

sterility of the product.

A) Mevatron Linear Accelerator

B) Oncor Impression 3D Plus

Siemens AG 2011-01-10 2010-11-25 59311 Type III A) 4504200

B) 5857912

A) 3291, 3356, 3619, 3645, 3638, 3919, 2618,

2616

B) 3799

In case of a breakage of the Beamview TI camera cable, it may be possible that the camera

housing is exposed to the operating voltage of 100 vdc. As a consequence of this exposure

the persons performing repair or maintenance tasks may sustain an electric shock. This

issue does not occur during normal clinical operation since cables and electrical

components are enclosed behind the covers.

A) Brilliance 64 Slice CT System - Extended Brilliance

Workspace (EBW)

B) Brilliance CT Big Bore System - Extended Brilliance

Workspace Portal

C) Brilliance ICT System - Extended Brilliance Workspace

D) Brilliance 40/64 Slice CT System - Extended Brilliance

Workspace Portal

E) Brilliance ICT System - Extended Brilliance Workspace

Portal

Philips Medical Systems (Cleveland), Inc. 2011-01-10 2010-09-29 59355 Type II A) 4550 110 02031

B) 4550 110 02101

C) 4550 110 02031

D) 4550 110 02101

E) 4550 110 02101

A) 80338, 7379

B) 80025

C) 11019

D) 80063, 80258

E) 80588, 80662

The displayed values in the CCA application for the Extended Brilliance Workspace should

be labelled as being the percentage of increase in the wall thickness between the end

diastolic and the end systolic states, but what is actually being displayed is the decrease in

wall thickness from the end systolic to the end diastolic state.

Kolibri Spectra Camera Kit Brainlab AG 2011-01-10 2010-11-30 59387 Type II 18117 5572110001 There exists a small probability that specific Spectra cameras may return incorrect data,

resulting in navigation inaccuracies or in stopping of camera tracking.

O-Arm 1000 Imaging System - Main Unit Medtronic Navigation, Inc. (Littleton) 2011-01-10 2010-10-18 58889 Type II 9732719 S/N'S 00213, 00263, 00243, 00144, 00304,

00358, 00334, 00174

Potential door cable failure.

Definition + Definition Flash Siemens AG 2011-01-10 2010-11-25 59312 Type III 77 40 769 60199, 60206, 60235, 60422 This update instruction provides optimization of main unit due to malfunction of the dose

modulation at child head sequence which may lead to bad image quality.

Vial-Mate Adaptor Baxter Healthcare Corporation 2011-01-10 2010-12-02 59460 Type II 2B8071 >10 Numbers, Contact Manufacturer Baxter has become aware that the Vial-Mate vial reconstitution device is not fully effective

when used with I.V. bags that do not contain a minimum amount of air. The Viaflex bags

currently marketed in Canada are not injected with air during production and may not

contain this minimum amount of air. Therefore, incomplete reconstitution may result when

the Vial-Mate device is used with the Viaflex bags.

A) Axiom Artis DTA

B) Axiom Artis FA Alpha

C) Axiom Artis MP Diagnostic

D) Axiom Artis DBC Magnetic Navigation

Updated recall # 56246 previously posted on 2010-09-13.


B) 5904441

C) 5904466

D) 59 17 054

A) 32070

B) 25006, 25055, 25076, 25147, 20002, 200188

C) 20069, 20070, 20151, 20163, 20215

D) 14041

A potential danger by the image intensifier system with perivision options. During perivision

the image system can sporadically crash. The customer has to repeat the perivision and to

apply contrast media and x-ray to the patient.

Greenlight PV Laser System American Medical Systems 2011-01-10 2010-02-17 53649 Type III 0010-1155 534g, 543h, 537g, 310c, 1 unknown It is possible for persons in the operating room to inadvertently back into the Greenlight PV

fibre at the connection to the laser console which may cause the fibre to break and cause a

burn.

A) 1.0T Signa Horizon Magnetic Resonance System

B) 1.5T Signa Horizon Magnetic Resonance System

C) 1.5T Signa Horizon LX Magnetic Resonance System

D) Signa 1.5T Excite HD - Magnet

E) 3.0T Signa HDX MR System - Main Unit

F) 1.5T Signa HDX MR System - Main Unit

G) Discovery MR750 MR System - Magnet

H) 1.5T Signa Infinity Twinspeed with Excite

I) Signa 3T MR System - Parts for Main Unit

J) Signa Excite 3.OT G3 Magnet

K) Signa HDXT 1.5T MR System - Main Unit

L) Discovery MR450 1.5T MR System - Main Unit

M) Signa HDI 1.5T MRI System - 16 Channel

GE Medical Systems LLC 2011-01-10 2010-11-02 56975 Type II A) M1800MA

B) M1000MA

C) M1000RA/RD/RF/RG

D) M1060LG

E) M3335JK

F) M3335J, M3335JA, M3335JG

G) M7000MA, M7000MC

H) M3000TD

I) M1060YW

J) M3333TD

K) Signa HDXT 1.5T MR System

L) Discovery MR450 1.5T MR System

M) S7504HP

A) All Serial Numbers

B) All Serial Numbers

C) All Serial Numbers

D) All Serial Numbers

E) All Serial Numbers

F) All Serial Numbers

G) All Serial Numbers

H) All Serial Numbers

I) All Serial Numbers

J) All Serial Numbers

K) All Serial Numbers

L) All Serial Numbers

M) All Serial Numbers

Potential for failure for users to provide an obstacle free service path outside the 200g field

& not having another trained person on site, resulting in death or serious injury to service

engineers.

Centricity Laboratory - Instrument Interfacing GE Healthcare IT 2011-01-10 2010-08-18 58393 Type III Instrument Interfacing Software Version 4.0.0.9 or Higher & Software

Version 4.1.0 or Higher

Under specific conditions the laboratory system may truncate a value on an instrument re-

run (eg. A result of 1.025 would be truncated at 1. And reported as 1.000).

Centricity Laboratory - Core Lab GE Healthcare IT 2011-01-10 2010-08-18 58397 Type II Core All Character User Interface (CUI) Versions /

Releases

Under specific conditions, the laboratory system may incorrectly, report results of 0 for tests

that have not yet been resulted.

Stealthstation S7 - Cart Medtronic Navigation, Inc. 2011-01-10 2010-11-08 58590 Type II 9733856 4501186856 Some system control units (SCU) manufactured April - July 2010 have a defect that may

result in the SCU losing communication, which may cause the optical tracking system to

intermittently cycle or stop working.

A) Discovery ST16 (Multislice) - Main Unit

B) Angioct FP16 System

C) Discovery SET16 PET/CT Scanner System

D) Discovery RX PET/CT Scanner System

E) Lightspeed 16 CT Scanner System

GE Healthcare Japan Corpoation 2011-01-10 2010-11-18 58887 Type III A) S9116LA

B) A90962AC

C) S9116LE/ME

D) S9116LR

E) B7868JA/JD

A) 00000369417CN1, 00000385376CN9,

00000391656CN6, 00000393942CN8,

00000411721CN4

B) 00000005070YC8

C) 00000404536CN5, 00000406414CN3,

00000388336CN0

D) 00000406672CN6, 00000413213CN0

E) >10 Numbers, Contact Manufacturer

Certain computed tomography dose index (CTDI) adjustment factors used for manual

calculation from technical reference manual (TRM) are incorrect, which may lead to

inaccurate CTDI manual calculation.

Heartstart FR2+ Semiautomatic Defibrillator - Main Unit Philips Medical Systems 2011-01-10 2010-11-30 59418 Type II M3860A, M3861A N/A Affected units may contain a component called a flash memory that was improperly

relabelled by a third party, and therefore Philips cannot with certainty identify the source,

quality, and date of manufacture of the component.

Sterile Intermediary Tube Sets Depuy Mitek 2011-01-10 2010-12-03 59521 Type II 281142 >10 Numbers, Contact Manufacturer This recall has been initiated because there is a potential that the sterile barrier seals on the

product pouch in the affected lots may not be completely sealed, which could result in a

possible breach of sterility.

Indura Closed-Tip Intrathecal Catheter Medtronic Inc. 2011-01-10 2010-10-01 57324 Type I 8731SC >10 Numbers, Contact Manufacturer Potential that the 11.4 cm introducer needle within certain lots of model 8731SC Intrathecal

Catheter Kits may exceed USP requirements for bacterial endotoxin.

A) ACL Elite

B) ACL Elite Pro

C) ACL 9000

Instrumentation Laboratory Co. 2011-01-10 2010-11-11 58956 Type II A) 0000880311

B) 0001000311

C) 0000990011

A) 05010100 to 10111176

B) 05010100 to 10111779

C) 00040105 to 09031882

During testing of the ACL 8000/9000/10000/ACL Elite/ACL Elite Pro, sporadically lowered

APTT results were observed with available IL locked PT/APTT test groups. (Specifically the

recombiplastin PT / synthasil APTT / recombiplastin PT/APPTT-SP test group).

Foley Catheter Tray Benlan Inc. 2011-01-10 2010-11-17 59025 Type III 85-5037 71499 Description reads "Urethral Catheter Tray" instead of "Foley Catheter Tray".

Legionella Growth Supplement Oxoid Limited 2011-01-10 2010-11-17 59075 Type II SR0110C 906009 Product may contain low level microbial contamination which could result in contaminated

media.

Elecsys Anti-Tg Roche Diagnostics GMBH 2011-01-10 2010-11-29 59326 Type III 04738578191 >100 Numbers, Contact Manufacturer There is a possibility to obtain falsely elevated anti-Tg results caused by the interaction with

high thyroglobulin (Tg) concentration (>2000ng/ml) present in patient sample.

Stryker Navigation System - Intellect Cranial Software Stryker Leibinger GMBH & Co. KG 2011-01-10 2010-11-30 59427 Type II 6000-650-000, 6000-650-100, 6000-651-000,

6000-651-200, 6000-652-000

3001, 3002, 3003, 3004, 3010, 3031 When the user imports two or more image series and changes the viewing direction for both

image series, there is a potential that the orientation of the second image series is not

stored correctly by the system. This could result in two different discrepancies: 1) the

automatic correlation algorithm may not achieve a good correlation result and 2) the second

image series may be shown with the wrong orientation.

Chemstrip 10A Roche Diagnostics GMBH 2011-01-10 2010-12-02 59429 Type III 11379208119 200013xx, 200014xx, 200015xx, 200016xx,

200166xx, 200168xx, 200169xx, 200309xx,

200310xx, 201438xx, 202010xx

Potential defect in the manufacturing process of the plastic support of the Chemstrip 10A

test strips for specific lots which can lead to a workflow interruption.

Ligasure Blunt Tip Laparoscopic Sealer/Divider Covidien LLC 2011-01-10 2010-12-09 59607 Type II LF1537 190307, 191224, 191661, 192093, 192664,

193207, 193331, 193333

Covidien is conducting a recall of specific lots of the Ligasure Blunt Tip Laparoscopic

Sealer/Divider. The recall is in response to reports that during surgical procedures the

device may energize when clamping without pushing the activation button.

A) NIM-Response 3.0 Patient Interface

B) NIM-Neuro 3.0 Patient Interface

Medtronic Xomed Inc. 2011-01-10 2010-09-27 56860 Type II A) 8253200

B) 8253410

A) 00439, 00483, 00611, 00608, 00268, 00484,

00264, 00585

B) 00585

1) Open channel on NIM 3.0 system, which was traced to internal cable strain relief that

could be too long. 2) An inductor (lead) could break free from the board inside the patient

interface.

1.5 mm Plate Walter Lorenz Surgical, Inc., Also Trading As:

Biomet Microfixation

2011-01-10 2010-10-26 58413 Type II 01-7110, 01-7112 753120 & 693500 Possibility of part number 01-7710 (1.5 6 hole regular double Y plate) package may have

contained another part number 01-7112 ( 1.5 6 hole long double Y) instead.

A) Imris OR Table Model T2X

B) Imris OR Table Model ORT100

Imris Inc. 2011-01-10 2010-11-29 59398 Type II A) N/A

B) N/A

A) Contact Manufacturer

B) Contact Manufacturer

These tables can become contaminated with fluids in an area that is not easily accessible

for cleaning.

EZ-OX Plus Ceodeux S.A.- Meditec 2011-01-10 2010-12-06 59631 Type III M70600055 All Serial Numbers 1. Instructions for use have not been provided to customers, including potential hazards

associated with improper use and handling by improperly trained personnel, could lead to

serious injury. 2. Customers not aware of the recommended 5 year inspection for these

regulators, ensuring their continued integrity and safe working operation.

EZ-OX Oxygen Regulator Western/Scott Fetzer Co. 2011-01-10 2010-10-22 59703 Type III ALQ 1967 All Serial Numbers 1. Instructions for use have not been provided to customers, including potential hazards

associated with improper use and handling by improperly trained personnel, could lead to

serious injury. 2. Customers not aware of the recommended 5 year inspection for these

regulators, ensuring their continued integrity and safe working operation.

Temperature Management System Cincinnati Sub-Zero Products 2011-01-10 2010-11-29 59357 Type II 233 S/N 061-3-00001 - 101-3-01389 Changes were made to the instruction manual.

A) RELI SSO HLA-B Typing Kit

B) RELI SSO HLA-DRB Typing Kit

C) RELI SSO HLA-DQB1 Typing Kit

Invitrogen Ltd. 2011-01-10 2010-12-15 59739 Type III A) 840.01

B) 810-45

C) 820.01

A) 5661465D, 5844125D, 6671423A, 7013623A,

7146763A, 7550195A, 7604755B, 7800175B

B) 6652726B, 6671456B, 7130186B, 7146876B,

7428496C, 7640426F, 7800066E, 7879316H

C) 6233005B, 6435925B, 6715065B, 7033115B,

7146895B, 7514185B, 7689765B, 7764665B,

7800025B

Software that has not been validated for diagnostic use has been utilized as the main quality

control release testing of the RELI SSO HLA Typing Kits. Upon further investigation,

interpretation using the approved manual analysis method has found false positives that

may cause a mistyping or no typing result.

A) Cobas Integra System - Acetaminophen

B) Roche Hitachi - Acetaminophen

Roche Diagnostics GMBH 2011-01-10 2010-12-16 59845 Type II A) 20767174322

B) 03255379190



The manufacturer revised the endogenous claims for the acetaminophen assay on all

systems. The limitations-interference section of the acetaminophen package inserts have

been updated to indicate the impact of icteric, haemolytic or lipemic samples with low levels

of acetaminophen. Captia Measles IgM Kit Trinity Biotech USA 2011-01-10 2010-11-03 59852 Type II N/A 019, 020 The quality control criteria for the kit are not met. The results of test runs are invalid. There

is no risk of a false positive.

SYNCHRON System(s) Immunoglobulin A (Ig-A)

Reagent

Updated recall #55480 previously

posted on 2010-09-13.

Beckman Coulter, Inc. 2011-01-10 2010-06-28 55480 Type II 467920 M812164, M902345, M808240, M810152,

M904324, M909608

Ig-A Reagent lots M812164 and M902345 contain an unidentified cross reacting antibody

that may yield falsely high Ig-A results in survey samples for immunoglobulins which are

formulated with Ig-M monoclonal antibodies.

A) Stellaris Vision Enhancement W/AVS

B) Stellaris Vision Enhancement W/AFS

C) Stellaris Vision Enhancement-Anterior Deluxe System

W/AVS & HSV

D) Stellaris Vision Enhancement W/AFS, HSV

E) Millenium Microsurgical System-Unit


posted on 2010-03-29.

Bausch & Lomb Inc. 2011-01-10 2010-02-15 53207 Type III A) BL11110

B) BL11120

C) BL12110

D) BL12120

E) CX1000BASE, CX3000, CX3000BASE

A) SYS01048, SYS01044, SYS01046,

SYS00921, SYS01065, SYS01037, SYS01097,

SYS01128, SYS00931, SYS00896, SYS00983

B) SYS01217, SYS01230, SYS01059,

SYS01040

C) SYS00397, SYS00656, SYS00806,

SYS00280, SYS00466, SYS00688, SYS00689,

SYS00661, SYS00509, SYS00169, & SYS00494

D) SYS00446, SYS00139, SYS00514,

SYS00136, SYS00170, SYS00447, SYS00171,

SYS00564, SYS00570

E) Contact Manufacturer

Alert issued on reports of sparking, charring, and fires on power cords reported by Hospira &

Abbott Nutrition which are similar to the ones used in Bausch & Lomb products.

A) Acuson Antares System-Main Unit

B) Acuson Antares System-Refurbished Unit

C) Acuson Antares System-With 5.0 Upgrades


posted on 2010-03-29.

Siemens Medical Solutions USA, Inc. 2011-01-10 2010-03-02 53440 Type III A) 5936518

B) 8653771

C) 10032746, 10032747

A) 111843, 111922, 111923, 112267, 10134,

111786, 112070, 11092, 10096

B) 111994

C) 114573, 116119, 116146, 115416, 115996,

113510, 116172, 116181, 116198, 116199,

113469, 115300, 114916, 116012, 116015,

115723

Advisory notice to notify affected customers of a software error encountered after running

through the following workflow steps 1) zoom in live image, 2) store a retrospective clip, 3)

go to exam review or an offline workstation, and measure the zoomed clip. Measured

results may be incorrect with no indication to the user they are wrong.

AMS Advance Male Sling System American Medical Systems Inc. 2011-01-24 2010-09-09 56924 Type II 72404224 615445001 thru 669783001 The results of the tensioning suture tensile testing were not consistent with previous

accelerated shelf life testing.

ETI-MAX 3000 Diasorin Inc. 2011-01-24 2010-01-22 59534 Type II 15950 9163500489 Potential failure of the 1000 ul dilutor syringe because of a faulty glue joint.

Surgipro Mesh (Multifilament Polypropylene Clear) Covidien LLC 2011-01-24 2010-12-16 59843 Type II SPM-35 A0K0490 The recall is undertaken due to the potential for the sterile barrier to be compromised.

A) Presice Cryosurgical System

B) SeedNet - MRI System

Galil Medical Ltd. 2011-01-24 2010-12-20 59424 Type II A) FPRCH2047

B) FPRCH2035

A) PI0051, PI0061

B) N/A

Discovery of damaged optocoupler during preventive maintenance. If optocoupler is

damaged and locking mechanism is in an 'unlocked' position the software will not alert of

the unlocked status which could result in patient or user injury.

Platelia Toxo IgG Bio-Rad 2011-01-24 2010-12-20 59953 Type II 72840 0D0017, 0D0117 Lower than expected R4A / R3 ratios that invalidate the assay when OD R4A / OD R3 falls

below 5.00.

Olympus Pediatric Resection Electrodes Olympus Winter & IBE GMBH 2011-01-24 2010-12-16 59988 Type II A37008A, A37009A, A37010A, A37011A, A37012A, A37013A All Lots, Contact Manufacturer During packaging validation testing, Olympus found that one of the sealing seams on the

sterile package may fail after exposure to external forces in certain simulated handling and

shipping conditions.

RENASYS Port - Foam Dressing Kit Port Smith & Nephew Inc. Wound Management

Division

2011-01-24 2010-12-21 59964 Type II 66800694 >10 Numbers, Contact Manufacturer Small holes in the primary pouch of some packaged units constitutes a breach in the

package integrity which compromise the product sterility.

SoftBank II v.23.1.2.x, 23.2.0.x,25.0.0 SCC Soft Computer 2011-01-24 2010-06-22 59204 Type II N/A 23.1.2.x, 23.2.0.x, 25.0.0.x Functionality issue: when SoftBank history reports for multiple patients were generated

using SoftReports. If more than one qualifying patient, each qualified patient has a report,

but all orders are listed under each patient, even those that do not belong to them. There is

no way to distinguish what results belong to a specific patient.

Expert DC Intraoral X-Ray System with Wall-

Mounting Plate

Imaging Sciences International, LLC DBA Gendex Dental

Systems

2011-01-24 2010-12-20 59976 Type II 110-0207G1 (120 VAC), D800WPEXPERT All Lots The wall-mounting plate is defective and could cause the unit to fall from the wall.

ABL80 FLEX CO-OX System Software 1.30,1.31 Radiometer Medical APS 2011-01-24 2010-01-07 60032 Type II 393-841 302069-70, 302070-72-74-76-79, 302080-81-82,

302092-93-98, 302100, 302140, 302178-79,

302018, 302021, 302023,302025, 302238

If during patient sample measurement, the (THB) parameter is not selected for reporting

then any results reported for the fractional hemoglobin parameters (SO2, FO2HB, FCOHB,

FMETHB and FHHB) will be values taken from a prior measurement and not associated

with the current patient measurement.

Ventilation Neonatal Unit Draeger Medical GMBH 2011-01-24 2010-11-21 60045 Type II 8415000 >10 Numbers, Contact Manufacturer Drager had been informed about one case in which the neonatal patient was not adequately

ventilated in high frequency oscillation (HFO) ventilation mode. The patient desaturated, no

permanent patient injury occurred. Investigations have shown that the instability of the

mean airway pressure caused insufficient gas exchange resulting in the desaturation of the

patient.

A) Ethanol 2 Assay

B) Ethanol 2 Reagent

Siemens Healthcare Diagnostics Inc. 2011-01-24 2010-12-17 59933 Type III A) 10379635

B) 10379635

A) 010, 020, 030, 040

B) 010, 020, 030, 040

Advia Chemistry Systems Reagent Blank (RBL) of Advia Chemistry Ethanol_2 Reagent

may fail calibration after the reagent has been onboard for 4-5 days, when any of the

following reagents Digoxin, ACET, LIP, DHDL, LDL, TBIL_2 and SAL (which contain

ethanol) are on board.

Sagittal Blade, Fine Linvatec Corporation D.B.A. ConMed Linvatec 2011-01-24 2010-12-10 59971 Type II 5023-138 180209 The Sagittal Blade was determined to potentially have a compromised seal thereby

compromising the sterility of the product.

A) Ultra IAB Catheter Kit

B) Percatneous Insertion Tray

C) Ultra 8 Intra-Aortic Balloon

Arrow International, Inc. 2011-01-24 2010-12-21 60049 Type I A) IAB-05830-U, IAB-05840-U

B) IAK-05845

C) IAB-05830-LWS, IAB-05840-LWS


B) >10 Numbers, Contact Manufacturer


There is an increase of "stuck in sheath" reports involving the use of the Super Arrow-Flex

Sheath with 5800 S series IAB products. When the IAB becomes stuck in sheath, the user

is unable to move the IAB catheter forward and backward, potentially causing a delay in

critical therapy.

5mm Absorbable Strap Fixation Device Ethicon Inc. 2011-01-24 2010-12-29 60059 Type II STRAP25 CJ6402, CKZ437 Ethicon is recalling all lots of Ethicon 5mm absorbable strap fixation device due to a

potential defect in packaging. This packaging defect could compromise the sterile integrity

of the device and/or may cause premature degradation of the absorbable straps.

INOmax DS INO Therapeutics, LLC DBA IKARIA 2011-01-24 2011-01-05 60062 Type II DS 20050006 >10 Numbers, Contact Manufacturer IKARIA is recalling the INOmax DS because it contains an oxygen sensor being recalled by

Teledyne instruments. The defect may cause impacted oxygen sensors to lose electrolyte. If

one of the INOmax drug-delivery systems contains a defective o2 sensor, the user may

observe erratic readings of nitric oxide (NO) during calibration of the system prior to or

during use with patients. Because the o2 sensor is housed within the system's monitoring

component, rather than the drug-delivery component, delivery of INOmax to the patient is

not immediately impacted.

Aspen Corneal Marking Pad Sterile Aspen Surgical Products, Inc. 2011-01-24 2010-12-23 60076 Type III 40490 2010-10-07, 2012-10-12, 2012-11-30, 2012-12-

15, 2013-04-19, 2013-04-23, 2013-05-21, 2013-

10-01

Fragments from the pad are disengaging and sticking onto the instrument. This condition

could cause fragments to come into contact with the intact cornea prior to surgery.

TheraScreen: K-RAS Mutation Kit Qiagen Manchester Ltd. 2011-01-24 2010-12-01 59917 Type III 05366259190, KR-41 DK262-01 A customer complaint was received for TheraScreen: K-RAS Mutation Kit lot DK 262-01,

which confirmed a labelling error with TAQ polymerase, one of the components packaged

within the kit. The TheraScreen: K-RAS Mutation Kit lot DK 262-01, is correctly labelled with

an expiration date of 27 April 2011, however, the TAQ polymerase (TAQ) packaged within

the kit is incorrectly labelled with an expiration date of 28 February 2011.

Aplio Artida Ultrasound System Toshiba Medical Systems Corporation 2011-01-24 2010-12-13 60048 Type II SSH-880CV W1B0862082, W1F0982231, W1F0982233,

W1F0982235, W1I1092449, WIF0982239,

WIF0982240

In Artida Ultrasound Systems, under certain conditions the operation panel can become

unresponsive (A "lockup").

Access Free T4 Calibrator Beckman Coulter, Inc. 2011-01-24 2010-11-29 59633 Type II 33885 014769 for Free T4 Calibrator Beckman Coulter has confirmed that the stability claims for Access Free T4 Calibrator, lot

014769, was not met.

Access Immunoassay Systems Alpha-Fetoprotein (AFP) QC

Kit

Beckman Coulter, Inc. 2011-01-24 2010-12-13 59925 Type III 33219 012781 Access AFP QC Kit Beckman Coulter has confirmed that kit lot 012781,(vial lots: QC1:012778, QC2: 012779,

and QC3: 012780) of Access AFP QC may contain a precipitate in all three QC levels

included in the kit.

NanoCross .014" OTW PTA Dilation Catheter

Updated recall #59261 previously posted on 2010-12-20.

EV3 Inc. 2011-01-24 2010-11-22 59261 Type I AB14W020080150, AB14W020120150, AB14W025120150 8778807, 8784857, 8811586, 8815410,

9248597, 9416365

Specific lots of the catheter may crack or break during use resulting in the inability to inflate

or deflate the balloon and can result in material separation and potential embolization.

A) PK7300 Automated Microplate System - Instrument Class 3

B) PK7300 Automated Microplate System - Instrument

Beckman Coulter, Inc. 2011-01-24 2010-11-29 59926 Type II A) PK7300

B) PK7300

A) All Lots

B) All Lots

Beckman Coulter has confirmed that on some systems, water may drip from unused

reagent probes during testing on the PK7300 Automated Microplate System.

Hydroset Injectable Bone Cement Stryker Leibinger GMBH & Co. KG 2011-01-24 2010-12-09 59942 Type II 397005 IC00874 Stryker has become aware that there is a potential for the package of Hydroset to contain

10cc of powder rather than the 5cc labelled on the box.

Stratus CS Acute Care Cardiac Troponin-I Testpack Siemens Healthcare Diagnostics Inc. 2011-01-24 2010-12-23 60053 Type II CCTNI 230201002, 230200002, 230242002,

230277002, 230305002,

230319002, 230263002

There is a low frequency of non-repeatable falsely elevated CTNI results without an

associated error message. These elevations may cause a sample that would be within the

99th percentile of the reference population, 0.07 ng/ml to read above this value. If this

occurs, the CTNI result would be expected to be discordant with the clinical picture,

including the classic rise and fall in concentration upon serial sampling.

Monaco RTP System - VMAT Option Elekta Business Area Software Systems ATA

Computerized Medical Systems Inc.

2011-01-24 2010-12-30 60326 Type II Monaco VMAT release 2.03 & higher For VMAT plans the QA (measured) dose is lower than Monaco's calculated dose.

Overestimation of dose in the treatment field is in the order of 5%.

A) Engstrom Carestation

B) Engstrom Carestation - Trolley Options


Datex-Ohmeda, Inc. DBA GE Healthcare 2011-01-24 2008-02-12 40775 Type II A) 1505-9000-000

B) 1505-8538-000


B) CBCL0047 TO CBCL00453 & CBCL00458

Dual fault failure mode of Engstrom system may occur that can cause patient airway

pressures to exceed the user settable PMAX limit.

A) Coulter Clone & Cyto-Stat/Coulter Clone T11 Monoclonal

Antibody

B) Cyto-Stat/Coulter Clone T11-RD1/B1-FITC Monoclonal

Antibody

C) Cyto-Stat/Coulter Clone T11-RD1/B4-FITC Monoclonal

Antibody

Beckman Coulter, Inc. 2011-01-24 2010-12-08 59930 Type III A) 6603849

B) 6603928

C) 6603801

A) 7295004F, 7295005F, 7295006F

B) 7252005F, 7252005R, 7252006F, 7252006R

C) 7221004F, 7221005F, 7221006F, 7221007F

There was a chance of failure to achieve prepared sample stability claims for CD2-PE

values after specimen is prepared with immunoprep reagent system and stored at room

temperature for 2 hours.

A) IFU for Monopolar Cord

B) IFU for Bipolar Cable

Stryker Endoscopy 2011-01-24 2010-12-31 60178 Type II A) 250-040-011

B) 250-040-016

A) All Lots

B) All Lots

Stryker has become aware that the testing from the supplier was missing/inadequate and as

a result the units have the potential to fail sterilization validation testing and cleaning

validation testing.

Verio Magnetom System Siemens AG 2011-01-24 2011-01-06 60321 Type III 10276755 40300, 40332, 40366, 40475, 40477, 40508,

40619

This update instructions (UI) should help to recognize faulty gradient cable connections and

subsequently prevent those from overheating. As part of the UI, thermal sensors (self-

adhesive labels) will be attached to the connections identified as critical.

RTP Software Monaco Elekta Business Area Software Systems ATA Computerized

Medical Systems Inc.

2011-01-24 2010-12-30 60327 Type II Monaco Release 2.03 & higher If the isocenter location is edited in the IMRT activity, the shift coordinates are not updated

in the IMRT plan report. The problem occurs when the isocenter shift coordinates are

defined in the sim activity and then edited in the IMRT activity.

A) Codman Disposable Twist Drill

B) Codman Metal Disposable ICP Kit, Adult

C) Ghajar Guide Ventriculostomy Kit

D) Codman Cranial Hand Drill


Codman & Shurtleff Inc. 2011-01-24 2010-12-02 59410 Type II A) 80-1200

B) 80-1190

C) 80-1185

D) 82-6607



C) 421302, 424870, 424871, 427693, 429015,

BB235, BB317, KB216, MB219

D) >10 Numbers, Contact Manufacturer

This recall is an expansion of the December 2010 Codman Disposable Twist Drill

recall. Codman has recently identified a packaging problem in certain lots of Codman

disposable drills. Cracks have been identified in the sterile package tray in which

these products are contained. The product in a cracked package may not be sterile

and could result in an increased risk of infection should it be used.

IFU for 33cm Laparoscopic Sterilization Tray Stryker Endoscopy 2011-02-07 2010-12-31 60174 Type II 250-015-500 All Lots Stryker has become aware that sterilization testing performed was inadequate [did not

simulate worst case use situations and most challenging sites] and therefore the gravity

steam sterilization duration has to be extended in the IFU.

i-STAT Celite Act Cartridges Abbott Point of Care Inc. 2011-02-07 2010-02-03 60279 Type III 07G01-01, 07G01-02 N/A Abbott has determined through internal studies, that i-Stat Celite Act Cartridges may exhibit

a higher than expected variability in reported results when stored at room temperatures for

periods of time in excess of 12 hours. There is no impact to reported results when cartridges

are stored refrigerated and warmed to room temperature for use within 12 hours.

TomoTherapy Treatment System - Kit Power TomoTherapy Incorporated 2011-02-07 2010-12-28 60304 Type II 101264 10332, 10333 TomoTherapy has discovered an anomaly during internal testing. If a TomoDirect

procedure, which consists of 2 to 12 beam angles, has an unrecoverable interrupt or

emergency stop during a short time period between beam angles, there is a small possibility

that the procedure will indicate a "performed" status rather than "interrupted" on the operator

station. If this occurs the user will not be able to generate a completion procedure.

TomoTherapy's investigation revealed that when an unrecoverable interrupt or emergency

stop occurs with <1 second remaining in a TomoDirect beam angle, the logic in the software

code checks if all the triggers (beam pulses) for the current beam angle is fully delivered

and marks the procedure as "performed", rather than interrupted as intended. The anomaly

is not taking into account if there are any remaining beam angles to be delivered.

Abbott Prism Reaction Trays Abbott Laboratories Diagnostic Division 2011-02-07 2011-01-06 60323 Type III 6A36-04 89898M500, 90044M500, 90359M500,

90579M500

Abbott has seen an increase in the number of drain time error codes when using Abbott

Prism HBSAG and Abbott Prism HIV O Plus Assays with the Abbott Prism Reaction Tray.

Liaison N-tact PTH Assay Diasorin Inc. 2011-02-07 2011-01-11 60448 Type II 310910 All Lots New reference ranges have been established for the Liaison N-tact PTH Assay using a

more detailed reference range study than initially performed when the assay was launched.

Prelude Short Sheath Introducer Merit Medical Systems Inc. 2011-02-07 2010-12-17 60462 Type II PSS-7F-4MT H179575 The introducer tip may detach and embolize during use. Alternately the tip material may

elicit a thrombogenic response.

A) Oxygen, Aerosol Masks and Face Tents

B) Hand Held Medication Nebulizer

C) Air Entrainment Masks

D) Aerosol Masks

E) Aerosol Mask, Power-Mist Medication Nebulizer

F) Power-Mist Medication Nebulizer

Unomedical Inc. 2011-02-07 2011-01-07 60125 Type II A) 100-E, 102-E, 103-E, 106-E, 107-E, 108-E, 110-E, 200-E, 202-E, 203-E, 3102-

E, 3104-E, 3224-E, 3226-E, 3230-E, 3266-E, 9102-E, 9106, 9106-E, 9108-E, 9226-

E, 93102-E, 93226-E

B) 953-E

C) 120-E, 182-E, 227-E, 245-E, 246-E, 282-E, 3120-E, 3227-E, 9104-E, 9182-E,

9222-E, 93227-E

D) 220-E, 222-E

E) 228-E, 777-E

F) 3773-E, 3776-E, 776-E, 93776-E, 9776-E, 9777-E






F) >100 Numbers, Contact Manufacturer

There could be a sticky substance on the inside and/or outside of the mask that may

manifest itself in approximately 6 to 8 months after manufacturing of the product.

Inotech Heparin Adsorbant Connectorate AG 2011-02-07 2011-01-21 60454 Type II HA-1-N N/A Inotech Heparin Adsorbant is being recalled because it is an unlicenced device that was

sold to healthcare facilities in Canada.

A) General Utility Tray

B) HSG Procedure Tray 5F

Medical Device Technologies, Inc. Also Doing Business As

Angiotech

2011-02-07 2010-12-28 60042 Type II A) GUTS1000

B) 660005000

A) 010220EO, 010220E0, 010320G0,

013120Y1, 028723JE, 82521PQA, 81631NZT

B) 00391Z97, 009620AK, 021422A7,

82341PEQ, 90261S5R, 91411UKV, 92721X4R

The sterile barrier of the packaging may be compromised.

i-Stat Cardiac Marker Control Levels 1, 2, 3 and Calibration

Verification

Abbott Point of Care Inc. 2011-02-07 2010-12-29 60280 Type III 06F12-02, 06F13-02, 06F14-02, 06F15-02 M102081, M102082, M102083, M10208 It was found that there was a higher than expected rate of values from control level 1 and

calibration verification level 1 that were outside of the value assignment sheet (VAS) limits.

Internal studies have determined that the presence of co2 in the head space of the vial is

the cause of high results. Venting the gas in the head space of the vial to remove any co2

that may be present prior to the thawing of the material has been shown to prevent the

occurrence of high results.

GT Drills Dentsply Tulsa Dental Specialties

Trading as Dentsply Endodontics

2011-02-07 2010-12-23 60309 Type III GTS3DC 5051208 The pack may contain drills of a smaller size than indicated by the label.

Advanced Perfusion System 1 Termo Cardiovascular Systems Corp. 2011-02-07 2010-08-12 56245 Type II 801763 1-1340 Failure of the o2 sensor leading to the occurrence of a calibration failure of the o2 sensor

within the EPGS of the System 1.

Infus O.R. Syringe Pump Baxter Healthcare Corporation 2011-02-07 2011-01-11 60650 Type III 2L3100, 6461500 >100 Numbers, Contact Manufacturer Baxter Corporation is providing notification that over-the-counter Energizer C size alkaline

batteries should not be used with Infus O.R. Syringe Pumps. This particular battery

incorporates a feature that may inhibit electrical contact and may affect the ability of the

pump to power up.

COULTER LYSE S III diff Lytic Reagent Beckman Coulter, Inc. 2011-02-07 2010-12-27 60297 Type II 6605523, 6605526, 6605360, 723585, 6605632, 178833, 6605122, 6603208 Lytic Reagent 101554F COULTER LYSE S III diff Lytic Reagent lot number 101554F was released for distribution to

customers prior to completion of QC testing. The material failed QC testing for hemoglobin

(HGB) and white blood cells (WBC).

Spectra Optia Apheresis System CaridianBCT, Inc. 2011-02-07 2010-12-13 60324 Type II 61000 1P00100-1P00719 The return line air detector is being added as a precautionary measure because the

manufacturer has received reports where excessive clotting (incident rate 0.009%) in the

extracorporeal circuit resulted in air entering the return line.

Latitude Secure Server Cardiac Pacemakers Incorporated 2011-02-07 2011-01-10 60523 Type III 6441 N/A Data within printed reports obtained from the Latitude Server since June 6, 2010 may not be

accurate. Specifically, when printing reports for more than one patient at a time, the most

recent presenting electrogram (MRP-EGM) for some of the selected patients may be either

missing or incorrect.

A) CADD-Solis Ambulatory Infusion Pump

B) CADD-Solis VIP Ambulatory Infusion Pump

Smiths Medical ASD, Inc. 2011-02-07 2011-01-14 60660 Type II A) 21-2101-0200-02, 21-2101-51, 21-2102-51, 21-2111-0100-51

B) 21-2120-0100-50



Smiths Medical has become aware of an increased trend in reports of the cassette lock

mechanism on certain CADD-Solis Pumps becoming stuck in the locked position, making it

nearly impossible to remove the medication cassette reservoir (or administration set). The

purpose of the cassette lock is to secure the medication cassette reservoir (or administration

set) to the pump.

A) Clinac Linear Accelerator

B) Clinac IX Radio Therapy Delivery System

Varian Medical Systems, Inc. 2011-02-07 2010-12-10 60671 Type II A) 2100C, 2100C/D

B) Clinac IX



The bolts used to fasten the counterweight to the gantry, may not, in some cases be fully

tightened to the required torque specification. In the worst possible scenario (which has

never occurred) this could result in the counterweight detaching from the gantry.

Aria Practice Management - 4D Integrated

Treatment Console (4DITC)

Varian Medical Systems, Inc. 2011-02-07 2010-12-14 60672 Type II V8.1.2, V8.6, V8.8 >10 Numbers, Contact Manufacturer Multiple isocenter plans will load on the 4DITC and are available for imaging and treatment,

but the 4DITC software does not recognize that multiple isocenters are present. Acquired

couch parameters can be applied to any or all fields in the treatment plan regardless of

isocenter definition. This involves product versions 7.029, 8.1.1.3, 8.1.3,8.1.4.0, 8.3.0.12,

8.6.1, 8.6.2.0, 8.8.1.7.

Acuson X300 Siemens Medical Solutions USA, Inc. 2011-02-07 2011-01-12 60723 Type III 10348531 315605 This letter is to notify you that we have determined that there is an error in the estimation of

mean pressure gradient in the cardiac measurement package available on all versions of

Acuson X300 Ultrasound Systems.

Dimension Clinical Chemistry System Siemens Healthcare Diagnostics Inc. 2011-02-07 2010-12-28 60301 Type III DF33A, 10444968 CA1260, BB1268 Dimension Clinical Chemistry System creatinine (CREA) flex reagent cartridges have the

potential for falsely elevated creatinine results for quality control and patient samples.

A) Endoplege Coronary Sinus Catheter, Model EP

B) Steerable Coronary Sinus Catheter, Model SCS01

Edwards Lifesciences 2011-02-07 2010-12-03 60295 Type II A) EP

B) SCS01


B) 666556, 669235, 678238, 751043, 755821,

763122

Edwards Lifesciences is recalling the EP and SCS01 Coronary Sinus Catheters due to

possible hemostasis valve displacement of the INTROCSC introducer component contained

in packages of these products. If the valve becomes displaced there is an unlikely chance

that the valve could be pushed through the sheath.

System 2450 120V Conmed Corporation 2011-02-07 2011-01-10 60798 Type II 60-2450-120 >10 Numbers, Contact Manufacturer Conmed has determined there is a chance that a sequence of events may lead to a

situation in which there may be leakage of electrical energy to the user or unintended

dispersive path for the patient if the unit is activated and could result in an electrical burn.

Bouffant Caps Trudell Medical Marketing Limited 2011-02-07 2010-08-25 56406 Type III T16199400DFL 100315 A report received to-date indicates that the ink used to make the butterfly pattern on the cap

may come off in a form of tiny blue particles. This may pose a safety risk.

Ascendra 2 Delivery System Edwards Lifesciences LLC 2011-02-07 2011-01-04 60740 Type II 9320AS23, 9320AS26 N/A Edwards Lifesciences is issuing a field safety notice to augment the instructions for use

(IFU) of the device to reinforce the correct preparation, orientation and hydration of the

transcatheter heart valve (THV) when it is loaded onto the Ascendra 2 Delivery System.

Edwards Lifesciences has become aware that loading at an angle (ie non-coaxial) may

unseat the valve within the loader, creating a leak path at the seal button. When the valve in

the loader is hydrated per the IFU this leakage is likely to be detected before use. If

observed, leakage can be easily resolved by manipulation of the seal buttons. Lorsque la

vanne dans le chargeur est hydratée selon la NDI, cette fuite pourrait probablement être

détectée avant l’utilisation. Les fuites peuvent être facilement résolues en manipulant les

boutons de fixation si elles sont décelées.

Greenlight II Laryngoscope Handle & Blade Vital Signs Inc. 2011-02-07 2011-01-12 60808 Type II 4558GSP >10 Numbers, Contact Manufacturer The Greenlight II Laryngoscope Handle with a top window battery cartridge may not function

correctly. If the handle is subjected to a force perpendicular to the long axis of the handle, a

battery may shift in the cartridge. This could result in an intermittent light source or loss of

light source.

Endore Implant Ormco Corporation

Also Trading as Sybron Implant Solutions

2011-02-07 2010-12-29 59634 Type III 01B-7L1 Sept. 2009 - Nov. 2010 Product labelled Endopore Implant, 01B-7L1, with 1mm collar, actually contains 2mm collar.

No safety/efficacy issues since collar is the same length and osteotomy is the same size.

A) Alaris PK Syringe Pump

B) Alaris CC Syringe Pump

C) Alaris Tiva Syringe Pump

D) Alaris GH Syringe Pump

CareFusion Switzerland 317 Sàrl 2011-02-07 2011-01-13 60718 Type II A) 80053UN01

B) 80033UND1

C) 80043UN01

D) 80023UN01





CareFusion is aware of three significant events involving Alaris Syringe Pumps

administering into a high negative (vacuum) pressure patient line which resulted in a bolus.

This condition may exist where the infusion line is shared with other high pressure medical

pumps such as extracorporeal blood pumps, dialysis pumps, cardiopulmonary bypass

pumps, or haemodialysis pumps.

Transvascular Insertion Tool Thomas Medical Products,

a GE Healthcare Company

2011-02-21 2010-12-23 60649 Type II TVI-07 S32830, S33028 Thomas Medical Products has recently become aware that in some instances the pouch

seal that maintains the sterility of the product may be weak or open and compromise the

sterile barrier.

Invitrogen ABC UniTray with TAQ Invitrogen Corporation 2011-02-21 2011-01-17 60792 Type III 78001-10 037 851612/883129 The TAQ polymerase is not amplifying DNA as intended. There is suspected contamination

that is causing the TAQ to not work properly. Kits which contain the affected lot of TAQ

(TAQ polymerase vial lot # 864459) are not useable unless a different lot of TAQ is used.

A) Agilent-Information Center

B) Agilent-Information Center Client

C) Intellivue-Information Center Client

D) Intellivue-Information Center

E) Intellivue-Database Server

F) Intellivue-Patient Link Documentation Center

Philips Medical Systems 2011-02-21 2010-11-25 60741 Type II A) M3150A

B) M3153A

C) M3151B

D) M3140, M3145, M3150, M3155

E) M3154

F) M3170







Users have replaced keyboards supplied or approved by Philips with multi-media-type

keyboards which have an audio volume adjustment and muting controls. This allows users

to easily mute audio alarms on the Intellivue Information Center or to reduce their volume.

The alarm audio volume on bedside monitors and client devices connected to the Intellivue

Information Center is not affected. Although the service and installation guide includes

warnings about the use of hardware and software not supplied by Philips, it does not specify

that ignoring the warning can result in loss of alarm annunciation or in the impairment of

central patient monitoring.

Gemini TF 64 PET/CT System - PET Subsystem Philips Medical Systems (Cleveland), Inc. 2011-02-21 2011-01-14 60742 Type II 4535 679 81361 N/A If 80 KVP is selected for a low dose CT on a Gemini 64 PET/CT, during the PET acquisition

the concurrent reconstruction will fail and the customer may think that their images were

lost. This may cause the customer to re-scan the patient.

Clear-Trac Flexible Reusable Obturators Smith & Nephew, Inc., Endoscopy Division 2011-02-21 2011-01-13 60801 Type III 72200899, 72200900, 72201796 >10 Numbers, Contact Manufacturer Smith & Nephew has found that specific lots of the cannulated reusable obturator will not fit

the disposable Clear-Trac cannula identified for use with the product.

Cysto-Care Urological Procedure Trays Coloplast A/S 2011-02-21 2011-01-27 61091 Type II N/A >10 Numbers, Contact Manufacturer These procedural trays contain a sterile pack of lubricant and/or an alcohol prep pad which

are manufactured by Triad Group and are currently under a recall because of contamination

concerns.

A) HMX Hematology Analyzer

B) Coulter MAXM Hematology Analyzer

C) Coulter MAXM Hematology Analyzer with Autoloader and

Reticulocyte

Beckman Coulter, Inc. 2011-02-21 2010-12-13 59923 Type II A) 6605523, 6605526

B) 6605122

C) 6603208

A) All Lots

B) All Lots

C) All Lots

Beckman Coulter has confirmed that the MAXM, MAXM AL, HMX and HMX AL analyzers

omit the tilde (~) character when the tilde is used as part of the sample id within a barcode

label scanned by the primary mode barcode reader. As an example, '123~456' would result

as '123456' with the tilde character omitted.

Synchron Systems Multi-Calibrator Beckman Coulter, Inc. 2011-02-21 2010-12-13 59928 Type III 442600 For Multi-Calibrator M805618, M907396 Beckman Coulter Inc., has confirmed that triglycerides (TG) results may recover lower than

expected values when using the Synchron Multi-Calibrator (Multical), lot numbers: M805618

and M907396.

A) Precedence System - 16 Slice

B) Precedence System - 6 Slice

C) Skylight Gamma Camera System

Philips Medical Systems (Cleveland), Inc. 2011-02-21 2011-01-14 60743 Type II A) 2169-3000A

B) 2169-3002A

C) 2160-3000A, 2160-3000B, 2161-3000B, 2161-3001B

A) N/A

B) N/A

C) N/A

Philips has recently become aware of collisions and excessive force exerted on the lower

portion of the detector arms of Precedence and Skylight Spect systems which many have

resulted in the detector arms breaking. A collision or excessive force may lead to a crack or

fracture in the upper portion of the arm, which may cause the detector arms to break and

the arm and detector to fall.

Lexicon K Files Labelled as Lexicon C Files Dentsply Tulsa Dental Specialties

Trading as Dentsply Endodontics

2011-02-21 2011-01-17 61001 Type III CF01025 1007002395 The pack may contain drills of a different type and a smaller size than indicated by the label.

The Lexicon K Files have been labelled as Lexicon C Files.

Body Pro-Lok Platform Med-Tec Inc. DBA Civco Medical Solutions 2011-02-21 2011-01-05 61069 Type III N/A >10 Numbers, Contact Manufacturer Some versions of the Body Pro-Lock SBRT Systems (platforms) have different lateral

platform position scale markers. Also affects platforms in systems MTSBRT001 ABD

MTSBRT001L.

Sanvic Pulsatile Nasal Irrigator Yiin Wang Industrial Co. Ltd. 2011-02-21 2011-01-14 61012 Type III SH953 N/A Unlicensed class II medical device, Sanvic Pulsatile Nasal Irrigator.

Sychron Systems Glucose Reagent (GLU) Beckman Coulter, Inc. 2011-02-21 2010-08-09 56166 Type III 442640 All Lots The Synchron Glucose (GLU) cartridge assay, being used in Synchron systems, did not

accurately measure glucose in some urine samples, resulting in a positive bias.

COULTER PrepPlus 2 Beckman Coulter, Inc. 2011-02-21 2011-01-17 61029 Type II 378600 All Lots Beckman Coulter has confirmed that the COULTER PrepPlus2 failed to sense that there

was no or low volume of reagent in the vial. When this occurred, no reagent or insufficient

volume of reagent was dispensed into daughter tubes and operator was not alerted.

enGen Laboratory Automation Systems Thermo Fisher Scientific OY 2011-02-21 2011-01-28 61214 Type II enGen J16XQH4J, JCT20Q3J Ortho Clinical Diagnostics has identified a software anomaly that can occur with analyzers

connected to the bypass modules listed on an enGen Laboratory Automation System using

TCAutomation software version 3.1.1 and below. When this anomaly occurs, it is possible

for a sample other than the intended sample to be aspirated, potentially leading to test

results being assigned to the wrong patient without error notification.

Reliance Synergy Washer/Disinfector Steris Canada Corporation 2011-02-21 2010-10-29 58918 Type III FH03072 3612510004, 3612410008 Synergy users may occasionally experience "RTD out of range" alarms and/or aborted

cycles due to temperature reading errors caused by an integrated circuit (IC) chip on the

printed circuit board in the units.

A) Lubricating Jelly

B) Necessaire A Catherisme Foley

C) Sterile Universal Foley Insertion Trays

D) Sterile Urethral Catherization Tray

E) Harmonized Laparoscopic Gynecology Pack

F) Hydterectomy Pack

G) Harmonized Gyne Peri Pack

H) Abdominal Aorta Pack

I) Open Heart Pack

J) Prostatetomy Pack

K) C-Section CDS Pack

L) Minor Cysto Pack

M) Major Cysto Pack

N) Gen Urology Minor

O) Harmonized Cystoscopy Pack

P) Harmonized TUR-LF Pack

Q) Harmonized Major MIS Lithotomy Pack

R) Harmonized Major Universal LF Pack

Medline Industries Inc. 2011-02-21 2011-01-10 60710 Type II A) M199110B

B) M102108X, M102116B, M102124B, M102124T, M102133X, M102136X,

M102144X, M102145A, M102147X, M102148X, M102149X, M102150X,

M102151X, M102225X, M102231X, M102270X, M102277A, M102277X

C) DYNDCA10160, DYNDCA18100, M102152X, M102284X, M102285X

D) M102140X, M102142X, M102143X, M102219X, M102245X, M102256X,

M102267X, M102271X, M102273X, M102278X, M102282X

E) DYNJ33325X

F) DYNJ33243X

G) DYNJ34958X

H) DYNJ33021X, DYNJ33316X

I) DYNJ33025X

J) DYNJ33019X

K) CDS982078X

L) DYNJ34384X

M) DYNJ34385X

N) DYNJ34457X

O) DYNJ33333X

P) DYNJ34959X

Q) DYNJ34955X

R) DYNJ34957X







G) >10 Numbers, Contact Manufacturer

H) >10 Numbers, Contact Manufacturer

I) >10 Numbers, Contact Manufacturer

J) >10 Numbers, Contact Manufacturer

K) >10 Numbers, Contact Manufacturer

L) >10 Numbers, Contact Manufacturer

M) >10 Numbers, Contact Manufacturer

N) >10 Numbers, Contact Manufacturer

O) >10 Numbers, Contact Manufacturer

P) >10 Numbers, Contact Manufacturer

Q) >10 Numbers, Contact Manufacturer

R) >10 Numbers, Contact Manufacturer

Medline Industries was alerted by Triad Group that a recall was being initiated. It has been

initiated due to concerns expressed by the FDA regarding the product. The recall is being

initiated because use of inadequately sterilized product might result in patient infection.

StealthStation S7 - Cart Medtronic Navigation, Inc. 2011-02-21 2011-01-11 60744 Type III 9733856 4501254366 Some navigation cameras manufactured between September and October 2010 may have

a faulty electronic component that can cause the camera to stop tracking instruments or

track instruments inaccurately.

Remington Medical 600-D Drainage Bag Remington Medical, Inc. 2011-02-21 2011-01-18 61102 Type III 600-D 083302 Recall initiated due to a potential of these draining bags to leak during patient use.

A) Alaris PK Syringe Pump

B) Alaris CC Syringe Pump

C) Alaris Tiva Syringe Pump

D) Alaris GH Syringe Pump

CareFusion Switzerland 317 Sàrl 2011-02-21 2010-12-10 60718 Type II A) 80053UN01

B) 80033UND1

C) 80043UN01

D) 80023UN01





CareFusion is aware of three significant events involving Alaris Syringe Pumps

administering into a high negative (vacuum) pressure patient line which resulted in a bolus.

This condition may exist where the infusion line is shared with other high pressure medical

cardiopulmonary bypass pumps, or haemodialysis pumps.

A) XVI X-Ray Volume Imaging System

B) XVI R4.5 X-Ray Volume Imaging System

Elekta Limited 2011-02-21 2011-01-05 60902 Type II A) MRT9451

B) MRT 13221

A) V.- 4.2, V.- 4.2.1

B) V.- 4.5

It is possible that XVI will not acquire data for a small section at the start and stop angles of

the flexmap acquisition. This can cause an error: isocenter displacement with 2D planarview

images acquired at +/- 180 degrees.

Horizon Cardiology Hemo System McKesson Medical Imaging Company 2011-02-21 2010-11-02 61031 Type III HCH-200 >10 Numbers, Contact Manufacturer McKesson has identified a rare scenario where the system's monitoring mechanism might

initiate a system restart during a clinical procedure. As a result, a labelling update is initiated.

CRW System - Intubation Head Ring Kit Integra Radionics, Inc. 2011-02-21 2011-01-12 61135 Type III HRAIM 0189463 Intubation hoops utilized in the manufacture of the HR-IM Intubation Head Ring assembly

have been produced with excess material beyond the pivot drill hole. When pivoting the

intubation hoop into the down position this excess material can come in contact with mating

accessories making it impossible to (A) pivot the hoop into its final downward position or (B)

prevent the accessories from being fully seated into the head ring assembly.

Cobas Integra S Transferrin Recept 80T Roche Diagnostics GMBH 2011-02-21 2010-09-09 61312 Type III 20763454122 62903801, 63306101, 63601901 Potential situation for occurrence of non mono flags on the Cobas Integra Platform when

calibrating with the tinaquant soluble Transferrin Receptor assay for identified lots.

Therakos UVAR XTS Procedural Kits Therakos, Inc. 2011-02-21 2011-02-01 61343 Type II XT125 >10 Numbers, Contact Manufacturer Therakos has received an increased rate of complaints of centrifuge bowl leaks for certain

lots of Therakos UVAR XTS Procedural Kits.

A) OneTouch Diabetes Management Software (v.2.3.2 &

2.3.3) and meter driver V.1.10

B) OneTouch Zoom Pro Diabetes Management Software V.5.1

LifeScan Inc. 2011-02-21 2011-01-31 61356 Type III A) 021-349, 022-150

B) 022-151

A) A-51841, A-58777, A-58278

B) A-58277

OneTouch Ping Meter Remote (with colour screen) does not operate properly with

OneTouch Diabetes Management Software or OneTouch Zoom Pro Diabetes Management

Software. This issue does not affect any other compatible devices with the software, it is

limited to OneTouch Ping Meter Remote with colour screen only.

A) Carescape Monitor B850 System -C1 CPU

B) Carescape Monitor B850 System - C1 CPU with third video

GE Medical Systems Information Technologies,

Inc.

2011-02-21 2011-01-14 59088 Type II A) 2020913-002

B) 2020913-003



Numerous different problems under specific conditions associated with the CARESCAPE

Monitor B850.

QUANTA Lite ANA ELISA Inova Diagnostics Inc. 2011-02-21 2011-01-21 61006 Type III 708750 N/A The HRP stop solution (cat 508509) a component of the kit was labelled with an incorrect

expiry date.

Reliance Endoscope Processor Steris Canada Corporation 2011-02-21 2010-12-22 61309 Type III MB000078, MB3001, MB3002, MB310447,

MB310448

3629002004 to 3616710006 The Reliance EPS experiences internal water leaks, interrupted cycles or nuisance fault

alarms even though no actual fault condition exists.

Cholangioscopy Access Balloon Wilson-Cook Medical, Inc. 2011-02-21 2011-01-14 60725 Type II DPOC-15 W2889216, W2910395 Product has been associated with complications including air embolism and gastro-intestinal

perforation with no direct failure of the device.

A) Kodak DirectView CR 850 System

B) Kodak DirectView CR 950 System

Carestream Health, Inc. 2011-02-21 2010-11-24 61257 Type II A) 854-7275

B) 132-7238

A) 3152, 3013, 3137, 3146, 3147, 3148, 3144,

3150, 3104

B) 3030, 3031, 3033

The Directview CR version 5.4 software used with the 24 x 30 cm type GP/PQ or HR

cassettes creates an image size which is 16 % smaller than true size. As a result images

smaller than true size will be printed, or displayed to the CR user interface or PACS

workstation. This will only occur when the true size option is selected within the image

editing menu. Other uses are not impacted.

System PHD EIA/IFA - Software Bio-Rad Laboratories Diagnostics Group 2011-02-21 2011-01-31 61332 Type II 4260246 AA00998-2.2, AA62587, AA70776-2.0A,

AA91575-2.1A,

BA70776-2.0A, BA91575-2.1A, BA90235,

CA90235

Even when a patient result fails a validation rule programmed into the assay, the

quantitative result (calculated value) will still be reported in the PHD worklist results and be

transmitted to the LIS (laboratory integrated system) if the user chooses to send the results.

A) Custom Sterile Cystoscopy Pack

B) Custom Sterile ABDOM Hysterectomy Pack

C) Custom Bowel Resection-Lithotomy Pack

D) Custom Sterile Pacemaker

E) Custom Sterile Bowel Resection Pack

F) Custom Sterile FEM POP Pack

G) Custom Sterile Urology Pack

H) General Surgery Pack

I) Custom Sterile Extremity Pack

J) Custom Sterile-Sterile Large LAP Pack

K) Laparoscopy Packs

L) Sterile T.U.R.P. Pack

M) Custom Sterile Kidney Pack

N) Custom General Gastro-Urology Packs

O) Custom Sterile Craniotomy Pack

P) Custom Sterile Dental Pack

Q) Custom Sterile General GYNE Pack

R) Custom Sterile Hysterectomy Packs

S) Custom Sterile Labour & Delivery Pack

T) Breast Packs

U) Laparatomy/Laparoscopy Pack

V) Vascular Pack

W) Aorta/Aneurysm Pack

X) By-Pass Pack

Y) General Cardiovascular Pack

Z) Abdominal Packs

AA) Custom Sterile Right Colectomy Pack

Cardinal Health 2011-02-21 2011-01-26 61358 Type II A) SBA30CPXXX, SOT30CYXXX

B) SMA30AHXXX

C) SBA30BLXXX

D) SAN30PIXXX

E) SOT30BA'XXX'

F) SCV30FPXXX

G) SBA30MU'XXX', SBA30UGXXX, SBA30URXXX, SOT30VAXXX

H) SBA30RBXXX, SBA30TVXXX, SUT30CAXXX

I) SOP30OSXXX

J) SBA30LL'XXX'

K) SLC30DV'XXX'

L) SBA30CYXXX, SBA30RPXXX, SBA30TPXXX, SBA30TUXXX, SOT30PRXXX,

SOT30RPXXX

M) SBA30DN'XXX'

N) SBA30UPXXX

O) SNE30CRXXX

P) SEN30MJXXX

Q) SMA30DL'XXX', SMA30PNXXX, SMA30VHXXX, SMA30VLXXX

R) SMA30HVXXX, SMA30HYXXX

S) SMA30BIXXX, SMA30CSXXX

T) SAN30BD'XXX'

U) SLC30LPXXX, SMA30LAXXX

V) SCV30VAXXX

W) SBA30AAXXX, SCV30DD'XXX'

X) SCV40OHXXX

Y) SCV30LOXXX

Z) SBA30ABXXX, SBA30RE'XXX'

AA) SBA30CD'XXX'

A) >10 Numbers, Contact Manufacturer /

>10 Numéros, Contacter le fabricant

B) >10 Numbers, Contact Manufacturer /


C) >10 Numbers, Contact Manufacturer /


D) >10 Numbers, Contact Manufacturer /


E) >10 Numbers, Contact Manufacturer /


F) >10 Numbers, Contact Manufacturer /


G) >10 Numbers, Contact Manufacturer /


H) >10 Numbers, Contact Manufacturer /


I) >10 Numbers, Contact Manufacturer /





M) >10 Numbers, Contact Manufacturer

N) >10 Numbers, Contact Manufacturer / O) >10 Numbers,

Contact Manufacturer / P) >10 Numbers, Contact Manufacturer

/ Q) >10 Numbers, Contact Manufacturer

R) >10 Numbers, Contact Manufacturer

S) >10 Numbers, Contact Manufacturer

T) >10 Numbers, Contact Manufacturer / U) >10 Numbers,

Contact Manufacturer / V) >10 Numbers, Contact Manufacturer

/ W) >10 Numbers, Contact Manufacturer

X) >10 Numbers, Contact Manufacturer

Y) >10 Numbers, Contact Manufacturer / Z) >10 Numbers,

Contact Manufacturer

AA) >10 Numbers, Contact Manufacturer

The Triad Sterile Lube Jelly component recall has been initiated due to concerns expressed

by FDA regarding the validation of the gamma radiation sterilization cycles for these

products. Cardinal Health Canada couriered a recall notification to affected customers on

January 28, 2011.

HC2 System Software ver. 3.0, Suite 4.0 Qiagen Gaithersburg, Inc. 2011-02-21 2011-01-12 61369 Type II 5050-00162, 5050-11140A, 5050-11240A,

5050-20000A

N/A There is a software defect relating to the use of the edit function on plates running two

digene HC2 assays on the same 96-well microplate. When an edit is made to a specimen

identifier associated with second assay protocol on the plate, an error occurs that causes the

edited patient specimen identifier to become associated with an incorrect digene microplate

luminometer reading.

Cement Restrictor, Size 3 Depuy Orthopaedics, Inc. 2011-02-21 2011-02-03 61458 Type II 546014000 ET5EA4 This recall is due to a manufacturing error resulting in a potentially incomplete seal of the

outer pouch. Although the sterility of the product is not compromised, the sterility of the

inner pouch containing the product cannot be assured. Lack of sterility of the inner pouch

could potentially cause contamination of the sterile field, including the implant.

Titan Surgical Table Trumpf Medizin Systems GMBH & Co. KG 2011-02-21 2011-02-01 61460 Type II 1228073 All Lots Trumpf has received two customer reports of the leg section of the table articulating without

prompting from the user. According to these reports and the analysis conducted thus far,

this independent movement can occur without particular circumstance or condition. Initial

findings have led Trumpf to assume for the safety of patients and users that unintended

movement could occur on any version of Titan without notice.

A) Xeleris 2 Workstation Imaging System

B) Xeleris Nuclear Medicine Workstation

C) Xeleris 3 Workstation Imaging System

GE Medical Systems Israel, Functional Imaging 2011-03-07 2011-01-19 59982 Type II A) H3900JH, H3900NM, S8006KA/KB/KC/KD

B) H3700JA/JB/KA/KB

C) XELERIS 3



C) 0000CZC94158R3000,

0000CZC94154WH002

1. Erroneous measurements on CT images identified. 2. Possibility of getting wrong

standardized uptake values (SUV) 3. Software issue in brain spect application may switch

between display of early and late images of dual scan studies.

BD FACS 7 Color Setup Beads Becton, Dickinson and Company BD Biosciences 2011-03-07 2011-01-10 60724 Type III 335775 83284, 87471 Some of this product has failed to successfully complete instrument setup. The instrument

setup required an additional tube of 7 color setup beads to be completed.

Fresenius 2008T Hemodialysis System Fresenius USA, Inc. 2011-03-07 2011-01-19 60933 Type III 190713 >100 Numbers, Contact Manufacturer The cursor on the dialysis screen may disappear and not respond to user input. This failure

is a consequence of discharge of electrostatic charge from the touchpad.

A) Lubricating Jelly

B) Urethral Catheterization Tray Vesical

C) Probe Installation Kit-Bladder Syringe

Omega Medical Products 2011-03-07 2011-01-11 61042 Type II A) 10-8472, LG-105

B) NIS-001, NIS-278, NIS-382, NIS-5006, NIV-001

C) NIS-001, NIS-039, NIS-067, NIS-088, NIS-090, NIS-382, NIS-440, NIV-001,

PAC-141




Recall initiated following an alert from Triad Group regarding potential problem with

sterilization that could result in patient infection.

A) Orbit 90 Subcutaneous Infusion Set

B) Orbit Micro Subcutaneous Infusion Set

ICU Medical Inc. 2011-03-07 2011-01-25 61376 Type I A) M1861, M2461, M2491, M309, M4261, M4291, P1861, P189, P2461, P2491,

P3061, P309, P4261, P4291

B) P1851, P1881, P2451, P248, P3051, P3081, P4251, P428



Continuation of the Triad alcohol wipe recall. Product is co-packaged with the Orbit 90

Subcutaneous Infusion Pump (device identifier # 228516) and the Orbit Micro

Subcutaneous Infusion Set (device identifier #538766). Recall is due to concerns about

potential contamination of the Triad Group's products with the bacteria, bacillus cereus.

Discovery QDR Bone Densitometer with Frax Software Tool Hologic, Inc. 2011-03-07 2011-01-25 61282 Type II Discovery-W, Discovery-WI 85130, 85025, 85091, 84963, 85123 The Frax software tool associated with some Discovery W and Discovery WI QDR series

bone densitometer systems is being recalled because it is not approved for distribution in

Canada.

PleurX Drainage Kits CareFusion Corporation 2011-03-07 2011-01-31 61459 Type II 50-7500B, 50-7510 All lots CareFusion was notified by Triad Group of a recall of alcohol prep pads which are included

in the PleurX Kits. The recall of the alcohol pads is due to concern over possible

contamination.

A) Symbiq One Channel Infuser

B) Symbiq Two Channel Infuser

Updated recall # 54403 previously posted on

2010-10-11.

Hospira Inc. 2011-03-07 2010-04-26 54403 Type I A) 16026

B) 16027



1- Increase frequency of white screen alarm code S006/S308/S408.

2- Potential of unrestricted flow when set is removed from the pump. Moreover, the

check flow stop alarm intended to warn users of free flow conditions may not

consistently operate as intended and may not reliably provide appropriate warning.

3- Reports of Symbiq Pump not detecting air in line.

A) Z-Med II

B) Coefficient PTV Catheter

NuMED Canada, Inc. 2011-03-07 2011-02-03 61435 Type II A) PDZ611

B) COE125

A) JZ-7536

B) JC-0563

NuMED Canada, Inc. incorrectly labelled and shipped product. Two lots have been

inadvertently switched and incorrectly labelled and shipped.

Dermabond Topical Skin Adhesive Ethicon LLC 2011-03-07 2011-02-07 61530 Type III AHV12, AHVM12 CJP841, CKE811, CKE512 Ethicon, Inc. is voluntarily recalling multiple lots of Dermabond Topical Skin Adhesive based

on reports that some units contained discoloured product in the vial, and may also have had

prolonged setting times.

Reliance Synergy Washer/Disinfector Steris Canada Corporation 2011-03-07 2011-01-03 61593 Type III FH03053 3622708005, 3606008002, 3632407010,

3629507005, 3621807006, 3617707008,

3631808004, 3622907004

Wires coming loose on the washer terminal box cause the motor overload to trip and to

overheat and melt.

Portex First Breath Oxygen Masks Smiths Medical ASD Inc. 2011-03-07 2011-02-10 61612 Type II 002610 09-50 On some masks, there could be a sticky substance on the inside and/or outside of the mask

that may manifest itself approximately 6 to 8 months after manufacture of the product. The

sticky masks could result in inconvenience and, in some cases, there is a remote possibility

of potential harm to patient.

A) Xario XG - Main Unit

B) Aplio XG Ultrasound System - Main

Toshiba Medical Systems Corporation 2011-03-07 2011-01-20 61319 Type II A) SSA-680A

B) SSA-790A



When scanning with imaging preset of fetal heart, pediatric heart, adult heart or coronary in

certain software versions of Aplio XG and Xario XG, the patient-contact surface of

transducer PST-65AT may become abnormally hot when a different imaging preset is

selected during the same study. This is a software issue.

ACTIVE Inhibin A ELISA Beckman Coulter, Inc. 2011-03-07 2010-08-13 56202 Type III 10-28100, 10-28100-4 992721, 992809 Beckman Coulter has confirmed that the lot numbers 992721 and 992809 for the ACTIVE

Inhibin A ELISA may not meet the stated analytical sensitivity of 1.0pg/ml.

QuickVue One-Step hCG Urine Test Quidel Corporation 2011-03-07 2010-11-23 59757 Type III 20109 706842 Due to a packaging error, Quidel has estimated that a small number (approximately 3) of

hCG kit boxes were packed with incorrect test cassettes. These incorrect tests were h. pylori

test cassettes.

CrossFt Suture Anchor with Two Hi-Fi Sutures Linvatec Corporation D.B.A. Conmed Linvatec 2011-03-07 2011-01-31 61296 Type II CFP-5502 211581 Two reports have been received that the driver handle of the 5.5 mm CrossFt Suture

Anchor has the incorrect colour. It should be black but is red.

Sireskop SX/SD Luminos Siemens AG 2011-03-07 2011-02-01 61361 Type III 10093754 >10 Numbers, Contact Manufacturer When the user presses the tilt buttons on the opti grip hard deep at the lower end of the

button, the button can become stuck under the housing. This may lead to unintended

continuous tilt movement of the system, with potential hazard to the patient.

A) Spherasorb Carbon Dioxide Absorbent

B) Loflosorb

C) Intersorb Plus

Intersurgical Incorporated 2011-03-07 2011-01-28 61370 Type II A) 2196, 2197

B) 2198

C) 2194, 2195

A) 1100392, 1101241, 1101426

B) 1101107, 1101427, 1101428

C) 1101240, 1101423, 1101902, 1102596

Possibility that loose granules may enter the inspiratory path of the breathing system. This

applies only to GE-ADU and Anmedic Q systems anaesthesia machines.

Continuous Flush Device 55UF130 Edwards Lifesciences LLC 2011-03-07 2010-09-29 60283 Type III 55UF130 58495701, 58480446 Edwards Lifesciences discovered that the flow rate of this device was incorrectly stated on

the box (case) label as 3 ml/hr, but was correctly stated on the unit pouch label as 30 ml/hr.

This error was limited to the two lots stated.

Lite Wand Xe with Storz Cable Thompson Surgical Instruments, Inc. 2011-03-07 2011-01-28 61311 Type III 40002X N/A These Lite Wands were originally classified as class I, however, upon discussion with Health

Canada, it was determined that this device could be exposed to fat and blood and is

therefore considered invasive and should therefore be considered a class II device.

HeartStart MRx Defibrillator/Monitor Philips Medical Systems 2011-03-07 2011-02-07 61507 Type II M3535A, M3536A N/A Under certain conditions the EtCO2 values and ventilation rate values can display

interchangeably (unexpectedly or random switch) either under the ventilation rate label or

the EtCO2 label.

VCare Stan, Small, Large Cervical Cup Conmed Corporation 2011-03-07 2011-02-15 61634 Type II 60-6085-100, 60-6085-101, 60-6085-102 090120X - 090731X Conmed has received complaints of cervical cup or uterine balloon detachment for the

VCare vaginal-cervical ahluwalia's retractor-elevators manufactured after April 11, 2008,

which may be related to user technique.

Tissue Retrieval System Anchor Products Company Inc. 2011-03-07 2010-12-13 60291 Type II TRS100SB, TRS175SB P86N through Q24N A metal component within the unit can break and cause a malfunction. Use of this product

may represent a potential health hazard if the metal component is not removed after

breakage.

Multi M-Luminos TF Siemens AG 2011-03-07 2011-02-02 61437 Type III 10093902 1070, 1071, 1072 This update instruction provides details for the exchange of the detector holder. A certain

serial number band of detector holders has weak welded seams. To avoid future breaking of

the detector holder's arm the affected detector holders will be exchanged.

Aria Radiation Oncology


2010-11-08.

Varian Medical Systems, Inc. 2011-03-07 2010-08-26 57958 Type II Vision (Version 6.5) H466050, H466051, H466052, H466053,

H466057, H466058

A behavior seen with Varian Treatment (VT) software when either connected to a

Siemens Linear Accelerator using Digital Mevatron Interface Protocols (DMIP) 5 or 6

in delivery of a conventional or IMRT plan with more than one field and/or when VT is

installed with the couch value propagation feature. The user may not be aware that

couch rotation values were updated for all user selected fields following the use of

the couch value propagation feature.

Architect 25-OH Vitamin D - Reagent Abbott GMBH & Co. K.G. 2011-03-21 2011-02-15 61697 Type III 3L52-25 01110L000 Customer complaints have been received for an error in the maximum on-board stability

time displayed on the Architect when using lot 01110L000. Upon loading a new kit of lot

01110L000 onto the Architect and scanning the barcode, the kit displays an incorrect on

board stability of 1680 hours, which would equal 70 days. The correct on board stability time

is 168 hours, which would equal 7 days. The reagent package insert (commodity 49-

2152/R1) states in the storage instructions section, "the Architect 25-OH Vitamin D 100-test

reagent kit may be stored on board the Architect I system for a maximum of 7 days." The

conversion of 7 days into hours is 168 hours.

Optiflux F250NRe Dialyzers Fresenius Medical Care North America 2011-03-21 2011-02-16 61779 Type II 0500325E 10HU02012, 10LU02016 Since October 28, 2010 FMCNA-RTG has received reports of 19 incidents of internal blood

leaks for Optiflux F250NRe Hemodialyzer lot 10HU02012. Quality trending analysis has

revealed that lot 10HU02012 demonstrated a higher blood leak rate than for lots proceeding

and following lot 10HU02012. Same thing for the lot 10LU2016.t faite dans le cas du lot

10LU2016.

Maxcem Elite Kerr Corporation 2011-03-21 2011-02-21 61829 Type III 34418 3360900 Complaint received that set time for Maxcem Elite was too short. Therefore when

restoration was placed on tooth it would not adhere properly.

Soft-Core Classic Ormco Corporation, Also trading as Sybronendo 2011-03-21 2011-02-21 61830 Type III ESC-03006CL 081006701 Packaging error. 6-pack of Soft-Core Classic size #30 verifier incorrectly packaged with 6-

pack of size #25 obturator.

OptiBond FL Adhesive Refill Kerr Corporation 2011-03-21 2011-02-21 61848 Type I 25882 N/A Labeling error OptiBond FL Adhesive Refill autobags actually contains OptiBond FL Primer

bottle.

LIFEPAK 20e Defibrillator Physio-Control, Inc. 2011-03-21 2010-06-08 55155 Type II 70402, 70507 >1000 Numbers, Contact Manufacturer Various AC and/or DC power source issues such as: no AC operating power and/or no DC

operating power.

UniCel DxC 800 Beckman Coulter, Inc. 2011-03-21 2010-08-16 56203 Type III 4764 A10407 The new moulded canister lids(gray lids) for the UniCel DxC 800 could crack over time

causing pressure and vacuum error.

A) InDura Intraspinal Catheter

B) InDura 1P One-Piece Intrathecal Catheter

C) InDura Closed-Tip Intrathecal Catheter

D) Catheter Revision Kit -Distal

Medtronic Inc. 2011-03-21 2010-09-03 56454 Type II A) 8703W

B) 8709, 8709SC

C) 8711, 8731, 8731SC

D) 8598, 8598A





Cephalad migrations of catheter fragments, which may remain in intrathecal space either as

a result of a catheter break, catheter shear or a physician's intentional decision not to

remove unused catheter. / Migrations de fragments de cathéter vers la tête, lesquels

pourraient se loger dans l’espace intrathécal, à la suite du bris ou du cisaillement d’un

cathéter ou de la décision d’un médecin de ne pas retirer un cathéter qui n’est pas utilisé.

External Pulse Generators Medtronic Inc. 2011-03-21 2010-10-15 59975 Type II 5388 >10 Numbers, Contact Manufacturer Model 5388 Dual-Chamber External Temporary Pulse Generators may be unable to power

up or may power down unexpectedly.

Access System - Thyroglobulin Antibody II Beckman Coulter, Inc. 2011-03-21 2011-01-26 61292 Type II A32898 012741, 014751, 016551, 016838 Beckman Coulter has confirmed customer reports of reagent pack to pack variability for the

access thyroglobulin antibody II (TGAB) reagent.

A) Gen-S Analyzer

B) Coulter LH 780 Hematology Analyzer

C) Coulter LH 750 Hematology Analyzer

D) Coulter LH 500 Hematology Analyzer


B) 723585

C) 6605632

D) 178833, 178834

A) All Lots

B) All Lots

C) All Lots

D) All Lots

Issue 1: As of January 1, 2011, some fields are transmitted to the LIS empty fields if the

year is greater than 2010.

Issue 2: If the 1G1 transmission format is used, specific fields from the retic parameter

group will not be transmitted.

Stryker Triathlon PKR Peg Drills Howmedica Osteonics Corporation 2011-03-21 2011-02-09 61673 Type II 5650-4-512, 5650-4-536 All Lots Stryker Orthopedics has identified a trend of complaints involving reports of the peg drill

cold welding to the drill guide causing the peg drill to cease functioning.

INSTI 24 Test Kit with out Support Materials Biolytcal Laboratories Inc. 2011-03-21 2011-02-11 62013 Type I 90-1007, 90-1008, 90-1009 B1A136, B1A135, B1A137 Reason for the recall: INSTI Kits that contain blotted membrane units from lot number

B1A128 may produce false positive results with the INSTI negative control or with a

patient's sample. Three lots of INSTI were manufactured with the affected membrane units

from lot B1A28: B1A135, B1A136, B1A137.

Water Soluable Lubricant DeRoyal Industries Inc. 2011-03-21 2011-01-21 61857 Type II 31-702, 31-704, 31-938 >10 Numbers, Contact Manufacturer DeRoyal is recalling the products after receiving a recall notice from the fabricator Triad-

Group. That recall is due to concern by the US FDA over validation of the gamma radiation

sterilization cycles.

Level 1 Normothermic IV Fluid Admin Set Smiths Medical ASD Inc. 2011-03-21 2011-02-24 61931 Type I DI-65HL, DI-75 1839591, 1839594, 1843949, 1870656, 1870658, 1873608, 1880864Smiths Medical has become aware of an increased trend in reports of kinking of the tubing

on certain sets. In some cases, the kink may lead to a decrease in the flow of fluid to the

patient. A reduction in flow rate may lead to a delay of therapy, which could result in patient

injury or death. / La société Smiths Medical a observé une tendance croissante parmi les

rapports sur les problèmes de tortillement ou d’enroulement des tubes de certains éléments.

Dans certains cas, ces conditions peuvent entraîner une réduction de l’écoulement de fluide

administré au patient. La réduction du débit peut retarder l’exécution adéquate de la

thérapie et causer des blessures au patient, voire entraîner sa mort.

Sterile Lubricating Jelly Triad Disposables Inc. 2011-03-21 2011-01-05 60513 Type II 10-8344, 10-8472, 10-8500, 10-8917, 10-8919,

IM-8919

10-8344, UPC 5073083440 This recall has been initiated due to concerns expressed by The Food and Drug

Administration regarding the validation of gamma radiation sterilization cycles. The recall

was initiated because use of inadequately sterilized product might result in patient infection.

/ Le présent rappel a été amorcé à la suite des préoccupations de la Food and Drug

Administration au sujet de la validation des cycles de stérilisation par rayonnement gamma,

car l’utilisation de tout produit dont la stérilisation est inadéquate peut entraîner l’infection de

patients.

Life Pulse High Frequency Ventilator

Model 203 and 203A

Bunnell Inc. 2011-03-21 2011-01-26 61783 Type II 203, 203A >10 Numbers, Contact Manufacturer Bunnell Incorporated has initiated a voluntary recall to upgrade the Life Pulse Software from

VP07 to VP08 in models 203 and 203a. The software upgrade addresses two primary issues

and a number of minor items recently identified by an independent software validation

analysis. / La société Bunnell Incorporated a amorcé un rappel volontaire afin d’effectuer

une mise à niveau du logiciel de l’appareil Life Pulse (modèles 203 et 203a) et de passer de

la version VP07 à la version VP08. La mise à niveau de logiciel vise à résoudre deux

problèmes principaux et un certain nombre de problèmes mineurs qui ont été récemment

identifiés dans le cadre d’une analyse indépendante portant sur la validation du logiciel.

Lucas 2 - Chest Compressor Jolife AB 2011-03-21 2011-02-16 61861 Type III 150000-01 >10 Numbers, Contact Manufacturer Specific Lucas 2 devices have been experiencing failing probes in the hood, causing the

device to malfunction and the led will start to flicker. / Des dispositifs particuliers de marque

et de modèle Lucas 2 ont présenté des problèmes de défaillance des sondes dans l’élément

du type couvercle, ce qui entraîne le fonctionnement défectueux du dispositif et un

clignotement des DEL de l’afficheur.

Galileo Echo Blood Bank Analyzer Immucor Inc. 2011-03-21 2011-02-15 61915 Type I 0087000 N/A The Galileo Echo Blood Bank Analyzer may capture an invalid blank image of a test well

and in remote instances, the system may generate a false test interpretation with no error or

warning message generated.

Unicel DXH 800 Coulter Cellular Analysis System Beckman Coulter, Inc. 2011-03-21 2011-02-07 61686 Type II 629029 All Lots Beckman Coulter Inc. has identified four issues with the Unicel DXH 800 Coulter Cellular

Analysis System: 1. Specimen tubes may fall out of a type A cassette when the analyzer

inverts the cassette in the mixing station, or when an operator manually inverts A cassette.

2. The DXH 800 may fail to meet the carryover specification for the WBC differential (DIFF)

when the WBC is greater than 70 x 103 cells/ul (70 x 109 cells/l). 3. The DXH 800 may fail

to meet the carryover specification for NRBC% when the WBC is greater than 50 x 103

cells/ul (50 x 109 cells/l). 4. The handheld barcode scanner does not read barcode labels

using NW 7 symbology.

Lin-X Linearity Control Beckman Coulter, Inc. 2011-03-21 2011-02-14 61777 Type III 628029 2681530K, 2661580K Beckman Coulter Inc. identified a problem with the barcode labels for the Lin-X (lot numbers

2681530k, 2661580k). The Unicel DXHT 800 Coulter Cellular Analysis System generated

the error message 'XML parsing error' when attempting to read the label for any Lin-X level

prior to analysis. An additional character that was included in the label caused the error.

A) Disposable Nebulizer Kit-Pediactric

B) Disposable Nebulizer Kit

Trudell Medical Marketing Limited 2011-03-21 2011-02-18 61943 Type II A) M0293777E

B) M0293776E

A) 1000800, 0900742

B) 1000783, 1000860

Components used in the production of Trudell's Nebulizer Kits have been identified as

recalled product manufactured by Unomedical, Inc. The issue with the recalled oxygen

masks is that there could be a sticky substance on the inside and/or outside of the mask that

may manifest itself in approximately 6 to 8 months after manufacture of the product. The

sticky masks could result in inconvenience and in some cases there is a remote possibility

of potential harm to the patient.

Mammomat Inspiration Siemens AG 2011-03-21 2011-02-08 61945 Type III 10140000 >10 Numbers, Contact Manufacturer Preventive improvement of tube arm movement together with Bucky Table in order to

reduce risk.

Gryphon P BR Anchor with Orthocord DePuy Mitek 2011-03-21 2011-02-25 61991 Type II 210814 3463735 DePuy Mitek is initiating a recall of specific lots of Gryphon BR Suture Anchors because of

the potential presence of small metal debris in the shaft component of the device, which

may have accumulated during the manufacturing process.

SoftPerm Contact Lenses CIBA Vision Corporation 2011-03-21 2011-02-18 61826 Type II SoftPerm >100 Numbers, Contact Manufacturer Potential for out of specification osmolality and pH.

A) Accolade TMZF Hip Stem - 132 (degrees)

B) Accolade TMZF Hip Stem - 127 (degrees)

Howmedica Osteonics Corporation 2011-03-21 2011-02-22 61940 Type II A) 6020-0537, 6020-3535

B) 6021-0435

A) 31390203, 31446602R

B) 31597206

Grit blast media was observed in the drive hole for lots containing Accolade TMZF Hip Stem.

A) Accu-Chek FlexLink Plus Infusion Set

B) Accu-Chek FlexLink Plus

Roche Diabetes Care AG 2011-03-21 2011-02-21 61990 Type II A) 05511038001, 05511046001, 05511054001

B) 05510945001, 05510953001, 05511020001

A) GWX 001 - GWX 206, GWY 001 - GWY 033

B) GWX 001 - GWX 206, GWY 001 - GWY 033

When inserting the Accu-Chek FlexLink Plus Infusion Set there is a potential for under

delivery due to a kinked/bent cannula. The impaired cannula may lead to reduced

functionality of the infusion set and potential under delivery of insulin. If this remains

unnoticed, it can result in elevation of blood glucose levels.

Acticlot dPT American Diagnostica Inc. 2011-03-21 2011-03-03 61637 Type II 824 101028 Testing has revealed a stability issue that affects on-board assay performance over time.

Based upon testing, we have revised the instructions for the Acticlot dPT test to reflect an

"on-board" rehydrated stability of the dPT activator reagent of 8 hours at room temperature.

A) Trusat Oximeter

B) Trusat Oximeter - with Expension Option

GE Healthcare Finland OY 2011-03-21 2011-03-01 61678 Type I A) 6051-0000-190, 6051-0000-192

B) 6051-0000-191, 6051-0000-193



Plastic enclosure on external power supply for Trusat Pulse Ooximeter may break, exposing

the electrical board & line voltage, which could result in burn or electrical shock to user or

caregiver.

A) T.E.S.S. - Insert Glenoidien

B) T.E.S.S. Embase Glenoidienne - without cement

Biomet France Sarl 2011-03-21 2010-12-16 61742 Type II A) P1700120, P1700178, P1700180

B) P1700110, P1700122, P1700124

A) All Lots

B) All Lots

Difficulty in insertion of anatomic insert PE (polyethylene) to cementless baseplate during

surgery.

A) Plum A+ Volumetric Infusion Pump

B) Plum A+3 Infusion Pumps

Hospira Inc. 2011-03-21 2011-02-15 61913 Type I A) 12391, 20679, 20792

B) 12618, 20678



Hospira has received customer reports of the Plum A+ Infusion Pumps with no audible

alarm conditions, which have been associated with failure of the piezoelectric assembly due

to component quality issues.

Sarn's Cardioplegia Sets Terumo Cardiovascular System Corporation 2011-03-21 2011-03-01 62094 Type II 16130 ME12, MK02 Due to a problem with the fem luer component of this device, air may be entrained into the

cardioplegia table line when negative pressure is applied to the circuit (during priming or

aortic root venting).

A) Cardiovascular Procedure Kit

(conducer no recirc.double spike)

B) Cardiovascular Procedure Kit (Cabaret de Perfusion)

Terumo Cardiovascular System Corporation 2011-03-21 2011-03-01 62095 Type II A) 71032

B) 73007

A) ME19, ME19R, MG21, MK09, MN01

B) MM11

Due to a problem with the fem luer component of this device, air may be entrained into the

cardioplegia table line when negative pressure is applied to the circuit (during priming or

aortic root venting).

CyberWand Dual Ultrasonic Lithotripsy System Gyrus ACMI, Inc. 2011-03-21 2011-03-02 62108 Type III CW-USLG, CW-USLS GAXXXXXXX0001 to GAXXXXXXX0226 A version of software associated with the CyberWand may cause sub-optimal performance

such that the device fragments stones at a slower rate than is normally expected.

A) Orbit 90 Subcutaneous Infusion Set

B) Orbit Micro Subcutaneous Infusion Set

ICU Medical, Inc. 2011-03-21 2011-01-28 59838 Type II A) M1861, M2461, M2491, M3091, M4261, M4291, P1861, P1891, P2461, P2491,

P3061, P3091, P4261, P4291

B) P1851, P2451, P3051, P4251



A small percentage of devices may become damaged in transit causing the needle to

become bent and/or the needle sheath to become dislodged.

Cardiovascular Review Station AGFA HealthCare N.V. 2011-03-21 2011-01-27 61451 Type II 60+00007792 N/A Echocardiography volume measurements that were performed within Cardiovascular

Review Station (CRS) were not reflected correctly in associated results management (RM)

reports. This occurred when echocardiography volume measurement data was not saved

correctly within the CRS persistence data and in the RM database. The issue was caused

when point-trace mode was enabled in CRS, a feature that was introduced in CRS 2.12.05.

A software upgrade to CRS 2.14.03.SU2 will be made.

A) Accu-Chek Inform II Meter

B) Accu-Chek Inform II + RF Meter


B) 05060303001

A) UU11038344, UU11006762, UU11006763,

UU11006766, UU12005334


Unexpected change in the configuration settings of the Accu-Chek Inform II and Accu-Chek

Inform II RF Meters caused by a loss of flash memory in the database of the meter.

AcT 5diff Series Hematology Analyzer Beckman Coulter, Inc. 2011-03-21 2011-02-21 61994 Type II 175356 All Lots There is a potential for erroneously high platelet (PLT), RBC, MPV, and hematocrit (HCT),

results to be generated. The erroneous results may occur on the first aspiration of a tube

and may occur without instrument generated messages. Testing has demonstrated an

average probability of occurrence of erroneous elevated platelet counts on the first

aspiration of a specimen tube of 0.6% with a 95% confidence interval of 0.21% to 0.99%.

von Willebrand reagent Siemens Healthcare Diagnostics Inc. 2011-03-21 2011-02-08 62032 Type III OUBD23 506510 The control recovery for Von Willebrand Reagent lot 506510 control plasma N and control

plasma P has been found out of range due to a performance issue of the affected lot.

Therefore, patient results cannot be released.

Precision Flow Disposable Patient Circuit - Low Vapotherm, Inc. 2011-03-21 2011-02-18 62122 Type III PF-DPC-LOW LF1101012 The precision flow is sounding an alarm and will not operate when some disposable patient

circuits are first inserted into the main unit.

Urethral Procedural Tray with Syringe Teleflex Medical 2011-03-21 2011-03-03 62126 Type II 67890, 68895 >10 Numbers, Contact Manufacturer The affected trays contain alcohol prep pads that are included in the scope of a field

correction initiated by triad group, who supplies the alcohol prep pads. This field correction

was initiated by triad group due to concerns about potential bacterial contamination of the

prep pads. If contaminated alcohol prep pads are used, there is a potential for infection to

occur.

Tomotherapy Treatment System - Main Unit Tomotherapy Incorporated 2011-04-04 2011-01-11 61948 Type II H-0000-0003 >10 Numbers, Contact Manufacturer With some specific plan types, the treatment planning system can over predict dose to

targets resulting in potential under dose. The plan elements necessary to encounter this

issue are sharp dose gradients with few, simple and small axial cross section targets located

off central axis.

Harmony LA / LED Monitor Arm Adapter Steris Corporation 2011-04-04 2011-02-28 62027 Type III LB61 05004909100005 Steris Corporation has learned that the Harmony LA / LED Monitor Arm Adapters may

become unstable when used in conjunction with lead shields or comparable medical devices

that exceed the weight and moment limitations of monitor arm adapter. The weight and

orientation of these devices may result in suspension system instability and damage to the

monitor arm adapters.

Edwards Balloon Catheter Edwards Lifesciences LLC 2011-04-04 2011-03-02 62082 Type II 9350BC20, 9350BC23 All Lots Edwards Lifesciences has discovered that the subject devices were shipped into Canada in

error without Health Canada compliance status under the licensing, investigational testing,

or special access provisions of the medical devices regulations. In addition, some lots of the

devices included instructions for use applicable to a 3 cm balloon device, not the 4 cm

balloon configuration of the subject devices.

BD Nokor Vented Needle Becton Dickinson 2011-04-04 2011-03-02 62125 Type III 305213 0007829 One lot of the vented needle (305213) was incorrectly labelled at the unit package level with

the non vented needle (305216) top web at the web at the unit packaging level. Case carton

and shelf carton were labelled properly with vented needle (305213) information.

A) Magnetom Espree

B) Magnetom Trio A Tim System

C) Magnetom Trio A Tim System-Upgrade

D) Magnetom Avanto, System


B) 10018221

C) 10018222

D) 7391167


B) 35109, 35120, 35130, 35368, 35382, 35421,

35434, 35442

C) 35049, 35056


This update instruction should help to recognize faulty gradient cable connections and

subsequently prevent those from overheating. Thermal sensors (self-adhesive labels) will be

attached to the connections identified as critical.

Precinorm PUC Roche Diagnostics GMBH 2011-04-04 2011-02-16 61881 Type III 03121313122 157086 Labelling error since the wrong version of the value sheet was provided for the product

Precinorm PUC lot # 157086.

Stem-Trol Control Cells Beckman Coulter, Inc. 2011-04-04 2011-02-28 62031 Type III N/A 24,25,26,27 Wrong expiration date of 2010 July 26 instead of 2010 June 26.

NAC MLL Needles Remington Medical, Inc. 2011-04-04 2011-02-18 62139 Type III NAC 1410MLL, NAC 1825MLL 083384 (NAC1410MLL), 083383

(NAC1825MLL),

090582 (NAC1825MLL)

Potential for the needle hubs to break during use.

Medi-Vac Specimen Sock Cardinal Health 2011-04-04 2011-03-07 62156 Type II 65652-123, 65652-124 1091745 The recall has been initiated due to a labelling issue. Cardinal Health has received one

report of customer receiving 65652-124 in a packaged labelled as 65652-123 with lot

number 1091745 manufactured 11/16/2009.

Pronto 7 (PDC SC) Reusable Sensor Masimo Corporation 2011-04-04 2011-01-28 62189 Type II 2920, 2951, 2952, 2953, 2954, 9147 All serial numbers from A83F90 and up. When performing an SpHb measurement in cold conditions, the Pronto-7 Rainbow

Reusable Sensor may incorrectly measure actual finger temperature. As a result, Pronto-7

spot check pulse co-oximeter may provide an incorrect SpHb measurement.

A) Synchromed EL

B) Synchromed II - Programmable Pump

Medtronic Inc. 2011-04-04 2011-01-16 61855 Type I A) 8626-10, 8626-18, 8626L10, 8627-10, 8627-18, 8627L10, 8627L18

B) 8637



Potential for a pocket fill during a Synchromed II or Synchromed EL implantable drug pump

refill procedure.

Precipost DT Hospira Inc. 2011-04-04 2011-02-15 61913 Type I 11005 All Serial numbers Hospira has received customer reports of the Plum A+ Infusion Pumps with no audible

alarm conditions, which have been associated with failure of the piezoelectric assembly due

to component quality issues.

A) Orthoralix DDE Panoramic Dental X-Ray System

B) Orthoralizx 9200 DDE Panoramic Dental X-Ray System

C) Orthoralix 9200 DDE Plus CEPH

Imaging Sciences International, LLC

DBA Gendex Dental Systems

2011-04-04 2011-02-17 62137 Type III A) 110-0199G2, 110-0199G4, 110-0234G3

B) 51050161WW, 51050181WW

C) P9200DDE, P9200DDEC, P9212DDE

A) N/A

B) N/A

C) N/A

There is an anomaly in the firmware which can cause message corruption during periods of

high network traffic that can distort the digital image being transferred from the x-ray system

to the PC.

COBAS AmpliPrep Sample Rack Roche Diagnostics Ltd. 2011-04-04 2011-02-16 61882 Type III 03051315001, 05078903001, 28122172001 2009/10, 2010/02, 2010/06 COBAS AmpliPrep Sample Racks are out of specification and may cause aborted runs.

Masimo Set Rad-8 Pulse Oximeter Masimo Corporation 2011-04-04 2010-12-22 62190 Type II 1844, 1959, 1961, 1963, 9192, 22595, 9019, 9049, 9073, 9193, 9165, 9174, 9190,

9194, 9212, 1845, 1960, 1962, 9195, 9224, 1964, 9020, 9050, 9074, 9166, 9175,

9191, 9213

Versions earlier than V1.3.1.0 Rad-8 devices have been noted to revert back to factory default settings after power cycle

despite the user having configured the device with custom settings previously.

Haemophilus ID Quad Remel Inc. 2011-04-04 2011-02-25 61992 Type II RE02460 982564 Incorrect expiry date printed on outside box (February 19, 2011) it should have been

January 19, 2011.

GEM Premier 4000 Analyzer Instrumentation Laboratory Company 2011-04-04 2011-02-24 62121 Type II 00025000000 06050100 to 11024479 In rare instances, a measurement (amperometric) spike can occur early in cartridge life on

the glucose and lactate sensors during patient blood analysis, leading to erroneously high

results with potentially severe impacts to patient treatment.

A) INFUSO.R. Pump

B) Mini Infuser System

Baxter Healthcare Corporation 2011-04-04 2011-03-04 62229 Type III A) 2L3100, 6461500

B) 2M8171, 6465300, 6465300R



On January 11 2011, Baxter Corporation notified customers that Energizer C-size alkaline

batteries should not be used with the INFUSO.R. Pump (recall number 60650). The purpose

of this new communication is to inform customers that: a second device, the Mini-Infuser

system, uses the same size battery and incorporates the same battery contact interface,

and, that other brands of C-size alkaline batteries may incorporate the same feature that

inhibits electrical contact.

A) DePuy Cement Restrictor

B) DePuy Cement Restrictor (Universal)

DePuy Orthopaedics, Inc. 2011-04-04 2011-03-08 62231 Type III A) 5460-10-000, 5460-12-000, 5460-14-000, 5460-16-000, 5460-18-000, 5460-20-

000, 5460-22-000

B) 5461-01-000, 5461-10-000, 5461-12-000



During the initiation of a global recall for specific lots of DePuy Cement Restrictors

regarding a packaging issue (recall number 61458), Johnson & Johnson Medical Products

identified that, due to an administrative error, the necessary medical device licence

applications had not been filed with Health Canada to sell these devices.

Hardinge Femoral Cement Restrictor DePuy International Ltd. 2011-04-04 2011-03-08 62237 Type III N/A >100 Numbers, Contact Manufacturer During the initiation of a global recall for specific lots of DePuy Cement Restrictors

regarding a packaging issue (recall number 61458), Johnson & Johnson Medical Products

identified that, due to an administrative error, the necessary medical device licence

applications had not been filed with Health Canada to sell these devices.

Maxi Sky 1000 ArjoHuntleigh Canada Inc. 2011-04-04 2011-02-22 61972 Type II LF20010, LF20011, LF20013, LF20014,

LF20015, LF20019

Lots from Jan. 2005 to Jan. 2011 Smoke emerging from certain models of Maxi Sky 1000 ceiling lift cassettes (motor).

BHM Medical V10 BHM Medical Inc. 2011-04-04 2011-02-22 62262 Type II 9120001, 9120004, 9120005, 9120008, 9120009 Lots from Jan. 2005 to Jan. 2011 Smoke emerging from certain models of V10 Bariatric ceiling lift cassettes (motor).

Elekta Synergy XVI R4.5 - MRT13221 Elekta Limited 2011-04-04 2011-02-07 61735 Type II MRT 13221 152164, 152159, 152160, 105871, 151940 If another patient is selected on the imaging system (XVI release 4.5) during the

transmission of end of treatment data from Desktop Pro R7.01 to R&V system, the XVI

information is prioritized and the end of treatment data is never received by the R&V

system. This leads to a potentially misleading dialogue on the R&V system that may result

in a re-treat of field just completed.

A) Liaison Analyzer - Instrument Class III

B) Liaison Analyzer - Instrument Class II

Diasorin Inc. 2011-04-04 2011-02-16 61842 Type III A) 15970

B) 15970

A) N/A

B) N/A

The contact manufacturer informed Diasorin Inc. of the potential for the premature failure of

certain cooling modules. The affected cooling modules were assembled incorrectly and as a

result heat generated by the Peltier (thermo-electric cooler) units of the cooling module may

not be properly dissipated. The heat build up may shorten the expected lifespan of the

cooling module. Failure of the cooling module could cause the temperature in the liaison

analyzer reagent area to exceed allowable limits.

Total Knee 2100 Ossur Americas Inc. 2011-04-04 2011-02-14 61927 Type II N/A Contact Manufacturer Some units of device contain back links that may compromise knee function prematurely.

Heavy use of prosthetic may result in patient injuries, due to possible failure of device.

HLA-DRB Typing Kit 50 Test Invitrogen Ltd. 2011-04-04 2011-03-16 62287 Type III 810-45 8801576H DRB3*01 and DRB5*02 alleles are not listed on the hit tables for both the manual

interpretation analysis method and the method using PMP (pattern matching program)

software. The user will not be able to get any typing results for the DRB Kit. In addition, no

HLA typing results will be given for DRB3*01 and DRB5*02 alleles.

A) HLA-A Typing Kit, Including Mastermix

B) HLA-B Typing Kit

C) HLA-CW Typing Kit

D) HLA-DRB Typing Kit, Including Mastermix

E) HLA-DQB1 Typing Kit, Including Mastermix

Invitrogen Ltd. 2011-04-04 2011-03-16 62288 Type III A) 830.01, 83022

B) 840.01

C) 850.01

D) 810-45, 81022, 86022

E) 820.01, 82022






Internal process discrepancies have been identified with regard to the RELI SSO products.

The listed products, used for HLA typing, were released to the market with aged oligos

(probes and primers) used in manufacturing without sufficient stability data to support this

practice. For previously assigned HLA typings using the affected kits, customers must

review and confirm the results using an alternate method.

King Systems LTS-D Airway King Systems, A Consort Medical Company 2011-04-04 2011-01-24 61402 Type II KLTSD405 201011-169 This recall has been initiated due to product below specified hardness. The tubes are too

pliable and would be difficult to use for intubations. There is a possibility that the tube could

fold over in the narrower areas of assembly. Supplier of LTS-D products noted in their

process and informed King Systems on January 21, 2011.

Pre Clean M Roche Diagnostics GMBH 2011-04-04 2011-02-16 62096 Type III 03004899190 63330401 Occurrence of septum missing on some bottles of Pre Clean M for lot # 63330401.

Cobas Integra Calcium Roche Diagnostics GMBH 2011-04-04 2011-03-03 62097 Type II 20763128322 630204-01 Imprecision and erroneous patient results observed with the calcium on Cobas Integra and

to a lesser extend on Cobas C501 systems using the reagent lot #630204-01.

A) CDI System 100

B) CDI 101

Terumo Cardiovascular Systems Corporation 2011-04-04 2010-10-11 61636 Type II A) 100

B) 101

A) 100-001 to 100-1687

B) 1070 to 1697

Accuracy of the displayed parameters revealed that users may not be aware that the

displayed values could be drifting or inaccurate.

Aria Software Varian Medical Systems, Inc. 2011-04-04 2011-02-07 62335 Type II Vision (Version 6.5) H831103, H833652 Immediately after creating a setup field in RT chart version 7.3.10, the focus reverts to the

treatment field. Varian has received reports that users have sometimes failed to notice this

focus, and have proceeded to delete MLC and other accessory components from the field,

in the mistaken belief they were acting on the setup field.

Medical Bed Model FLH668DCM Stryker Medical 2011-04-04 2011-03-09 62361 Type II FLH668DCM All Serial numbers There is a potential for either the head section or the foot section of the bed to drop

unexpectedly, if preventive maintenance of the screw box has not been conducted.

Sarns Ultrasonic Air Sensor Cable Terumo Cardiovascular Systems Corp. 2011-04-18 2011-03-10 58270 Type II 149892, 78-8067-7375-6 29396 False alarms conditions where the user reported being able to reset the alarm and other

times not being able to reset the alarm to allow further air bubble detection.

Spirit 3000 Dental Chair Pelton and Crane 2011-04-18 2011-03-03 62140 Type III 3003, 3004 16964, 16934 The link arm assembly that connects some rear mounted options (cuspidors, assistants

instrumentation, and hygiene systems) to the Spirit 3000 Dental Chair may break and fall of

the dental chair.

A) HMX Hematology Analyzer


Beckman Coulter, Inc. 2011-04-18 2011-02-28 62152 Type II A) 6605523, 6605526

B) 178833

A) 6605522, 6605523, 6605524, 6605525,

6605526, 6605527

B) 178832, 178833, 178834

Beckman Coulter has identified an issue with suspect counterfeit integrated circuit (ICS)

chips have been found in LH500 and HMX units at installations and in instrument

manufacturing.

A) External Nasal Splint Kits

B) Thermasplint Kits

Medtronic Xomed Inc. 2011-04-18 2011-02-24 62165 Type II A) 1528116, 1528126, 1528136

B) 1529100, 1529110, 1529120

A) All lots since January 2008

B) All lots since January 2008

The alcohol prep pads contained in the kits may be contaminated with bacillus cereus.

Electric Bed Model FLH668NDCM Stryker Medical 2011-04-18 2011-03-09 62221 Type II FLH668NDCM All lots Stryker Medical has become aware that the medical bed model [originally manufactured by

Bertec Medical] has the potential for either the head section or the foot section of the bed to

drop unexpectedly, if preventive maintenance has not been conducted, as specified in the

owner's manual.

Cobas 4800 - Cobas X480 Module Roche Molecular Systems, Inc. 2011-04-18 2011-03-10 62268 Type II 05200890001 55152192, 55151324, 55154131, 55152629 Occurrence of misadjustment of the iswap (automated plate handler) component of the

Cobas 4800/Cobas X480 sample preparation module. This situation could be linked to a

possible cross contamination during sample preparation.

A) Prick Lancetter

B) Quintest Skin Test Device

C) Quintip Individual Skin Test Device

D) Small Pox Needle

Hollister-Stier Laboratories LLC 2011-04-18 2011-03-15 62327 Type II A) N/A

B) N/A

C) N/A

D) N/A

A) >10 Invoice Numbers, Contact Manufacturer t

B) Invoice / Facture # 575174

C) Invoice / Facture # 561327, 569864, 622540,

639811, 641983, 641984, 678141, 729967

D) >10 Invoice Numbers, Contact Manufacturert

Inspection of Canadian importer Omega Laboratories Ltd indicated this unlicensed product

was being imported for sale.

A) Argon Arterial Catheter Kit

B) PCI Kit with Feathered Dilator, Pediactric

Argon Medical Devices Inc. 2011-04-18 2011-03-14 62404 Type II A) 498100, 498104, 498106, 498447

B) 496310, 496311

A) 99768223, 99768103, 99767388, 99767634

B) 99768100, 99767643

A number of multi-purpose kit blister trays were found with a hole in them. The defect could

impact the sterility of the product which could potentially cause infection or an adverse

reaction.

Reflection 3 Acetabular System - INTL Ceramic Acetabular

Liners

Smith & Nephew, Inc. 2011-04-18 2011-03-14 62299 Type II 71331648, 71331652 10FT43676, 09JT35943, 10FT43611 During the manufacturing phase for certain batches of the R3 ceramic acetabular liners, the

titanium rings were pressed onto the ceramic component with a higher force than allowed by

the manufacturing specifications. This has the potential to result in lower than expected

strength for the liners.

A) Axiom Aristos FX Plus

B) Axiom Aristos FX


B) 7414803

A) 1042, 1189, 1191, 1192


The update instruction will inform customers about potential danger of Aristos FX and

Aristos FX Plus Systems having an older version of the detector alpha rotation assembly,

where the screws of the clutch assembly may break causing a hinge down of the detector

unit.

A) Accu-Chek FlexLink Plus Infusion Set

B) Accu-Chek FlexLink Plus


Roche Diabetes Care AG 2011-04-18 2011-02-21 61990 Type II A) 05511038001, 05511046001, 05511054001

B) 05510937001, 05510945001, 05510953001, 05510961001, 05510970001,

05510988001, 05510996001, 05511003001, 05511020001, 05511089001

A) GWX 001 - GWX 206, GWY 001 - GWY 033

B) GWX 001 - GWX 206, GWY 001 - GWY 033

When inserting the Accu-Chek FlexLink Plus Infusion Set there is a potential for under

delivery due to a kinked/bent cannula. The impaired cannula may lead to reduced

functionality of the infusion set and potential under delivery of insulin. If this remains

unnoticed, it can result in elevation of blood glucose levels.

Rapid Response HUT Table Medical Positioning, Inc. 2011-04-18 2010-05-05 62293 Type II 1017, 1117, 1217 598972 to 600809 The head-up tilt function may intermittently fail.

Hitachi/Cobas Integra Preciset sTfR Roche Diagnostics GMBH 2011-04-18 2011-03-11 62426 Type III 12148331122 63793501, 64243701 Occurrence of non mono flags on the Cobas Integra platform when calibrating the tinaquant

soluble transferrin receptor assay.

Millar Disposable Angiographic Catheter (Left Heart) Millar Instruments Inc. 2011-04-18 2011-03-09 62430 Type I SPC-454D >10 Numbers, Contact Manufacturer Potential that the catheter contains small particles of epoxy debris within the catheter lumen.

SureStep Flexx Blood Glucose Bedside Unit LifeScan Inc. 2011-04-18 2011-03-06 62469 Type III 020-185, 022-328 N/A Some SureStep Flexx Blood Glucose Bedside units (hospital meters) may not download

data from the meter, when the meter is placed in the cradle with connection module, to the

central repository (work station) at the hospital. This does not impact any other meter

functionality.

Curvtek Eye Needles Biomet Sports Medicine 2011-04-18 2011-03-10 62301 Type II 906764 748730 Certain lots were labelled sterile, but were not.

Padgett Model S Slimline Electric Dermatome Kit Integra Lifesciences Corporation 2011-04-18 2011-03-16 62344 Type II 3539-700 S-386, S-723, S-907 Three lots of this power supply were built with a single layer of insulation used in the

transformer, instead of the 3 layers minimum per product specification. Safety regulations

require a minimum of 2 layers of insulation in the transformer. These devices may not meet

required medical device electrical safety standards and may result in an increased potential

for electric shock.

A) CS300 Intra Aortic Balloon Pump System

B) CS100 Intra Aortic Balloon Pump

Datascope Corporation 2011-04-18 2011-03-23 62466 Type II A) 0998-00-3023-XX

B) 0998-00-3013-XX

A) S807282-E3, SL15602-1C9, SL135791GB

B) SA04837-L5, SA01419-A4

The fan assembly of the power supply for certain system 98/98XT, CS100/CS100I and

CS300 IABPS could potentially contain a misshapen retaining ring. This retaining ring could

disengage within the fan, causing the fan blade assembly to stop rotating. Consequently,

the power supply would detect an overheating event, and shut down without visual or

audible alarms.

A) Plum XL

B) Plum XL Micro/Macro Infusion System

C) Plum XL 3 Multi-Line Infusion System

D) Plum XL 3 Micro/Macro Infusion System

E) Plum XL Micro/Macro Infusion / Data Port

Hospira Inc. 2011-04-18 2011-02-14 62511 Type II A) 11555

B) 11846

C) 11781

D) 11845

E) 11859






Hospira has received complaints for the Plum XL Infusion Pumps related to no audible

alarm conditions. Users reported that during an alarm condition, the pump displays a visual

alarm, but the alarm buzzer does not audibly sound.

Selenite Broth bioMérieux, Inc. Portland 2011-04-18 2011-01-21 60979 Type III T3560, T7340 >10 Numbers, Contact Manufacturer Several lots of Selenite Broth were manufactured using selenite cystine broth instead of the

intended raw material, selenite.

NX Modality Workstation Agfa HealthCare N.V. 2011-04-18 2011-03-07 62157 Type II N/A Software Versions 2.0 .8100, 3.0 .8100, 2.0

.8200, 3.0 .8200,

2.0 .8300, 3.0 .8300, 2.0 .8400, 3.0 .8400, 2.0

.8500, 3.0 .8500

An image can be presented with the wrong patient name displayed above it. This can cause

confusion for the user and possibly result in the incorrect application of image markers or

annotations.

TEG Hemostatis Analyzer-Controls Haemonetics Corporation

D.B.A. Haemoscope Corporation

2011-04-18 2011-03-04 62267 Type II 8002 HMO #196, HMO #197 MA control test is out of range (low).

A) PainSmart IOD (Ambulatory Infusion Pump)

B) 6000 CMS (Ambulatory Infusion Pump)

Zevex Inc.

Also trading as: Moog Medical Devices Group

2011-04-18 2011-03-07 62274 Type I A) 360-1200, 360-1300, 360-1300P

B) 360-1100, 360-1400



There is the potential for a possible delay in therapy that may result during the use of

software version 6R9, 6R9A, 6R9B, 6R9C, 6R9D and 6R9E. Pumps programmed with

previously mentioned software revisions may display a false error code 45 (motor condition

loss of sync). This software anomaly renders the device in-operable until a recovery

process is performed. Recovery from error code 45 requires a power cycle of the pump

during which the date, time and all customized therapeutic parameters are lost. The

recovery process requires all such parameters to be re-inputted by the clinician prior to

beginning or resuming therapy.

Codman Enterprise Vascular Reconstruction Device Codman & Shurtleff, Inc. 2011-04-18 2011-03-21 62527 Type III ENF452812 1421338, 1421601, 1422396, 2420432 There is a typographical error on one of the 4 peel-off stickers that are placed on the subject

product packaging. The information on one of the stickers on the sterile pouch inside of the

product box indicates the stent size to be 22mm in length, when in fact the product is 28mm

in length.

Confidence Introducer Needle, Diamond DePuy Spine, Inc. 2011-04-18 2011-03-25 62528 Type II 2839-03-611 HLPB4G The issue detected is that the package, which is properly labelled (11GX 6-inch), contains a

13GX 4-inch side-hole needle. As the needle contained within the affected package is two

inches shorter in length, it could result in an inability to get the shorter needle to the desired

location.

Oxygen Sensor Teledyne Instruments, Analytical Instruments 2011-04-18 2010-12-07 60029 Type II R-15 617654, 617655, 617656 A limited number of Teledyne R15 oxygen sensors were found to leak electrolyte gel.

A) King LT-D Kit (Size 3, Size 4, Size 5)

B) King LTS-D Kit (Size 3, Size 4, Size 5)

C) King LT-D Kit (Size 2, Size 2.5)

King Systems, A Consort Medical Company 2011-04-18 2011-01-14 62044 Type II A) KLTD213, KLTD214, KLTD215

B) KLTSD413, KLTSD414, KLTSD415

C) KLTD212, KLTD2125

A) ITI16, IUAL9, IRMS3, IU2U7, IU7M5, IU2U8,

IU6V7, IUBN6



King Systems has been notified by Triad Group, our supplier of sterile lubricating jelly, that a

recall has been initiated for this product because the product may be "inadequately

sterilized" and use of this product may result in "patient infection". This particular sterile

lubricating jelly is packaged in the King LT-D Kit and King LTS-D Kit, so King Systems is

notifying our customers of the recall.

A) Carescape Monitor B850 System - C1 CPU

B) Carescape Monitor B850 System - C1 CPU with Third Video

GE Medical Systems Information Technologies, Inc. 2011-04-18 2011-03-28 62542 Type I A) 2020913-002

B) 2020913-003



1) Cardiac output values may be calculated incorrectly if default catheter settings used. 2)

ECG "leads off" alarm may not be activated with a specific user workflow, which could lead

to complete loss of ECG monitoring.

A) InterLink System Secondary Medication Set

B) Basic Solution Set

C) Continu-Flo Solution Set

D) Buretrol & Interlink System Buretrol Solution

E) Transfer Set

F) Secondary Med Set with 18G Needle Lock

G) Extension Set

H) MiniVolume Extension Set

I) InterLink System Extension Set

J) ClearLink System Extension Set

K) ClearLink System Non-DEHP Micro-Volume Extension

L) Mini-Infuser Microbore Extension Set

M) Basic Solution Set with Duo-Vent Spike

N) Solution Set with Duo-Vent Spike

O) InterLink System Basic Solution Set

P) InterLink System Solution Set

Q) InterLink System Vented Basic Solution Set

R) Interlink Basic Solution Set, Polyeth Lined

S) InterLink Solution Set with Restrictive Tubing

T) InterLink System Solution Set with Duo-Vent Spike

U) InterLink Non-DEHP Solution Set with Duo-Vent

V) ClearLink System Solution Set

W) ClearLink System Slotion Set with Duo-Vent Spike

X) InterLink System Continu-Flo Solution Set

Y) ClearLink System Continu-Flo Solution Set

Z) Nitroglycerin Set with Duo-Vent Spike

Baxter Corporation 2011-04-18 2011-03-15 62362 Type III A) JC7451

B) JC5383, JC5387, JC5417, JC5418, JC5421, JC5423, JC5425, JC5439,

JC5442, JC8109

C) JC0430, JC5380N, JC5386N, JC5537N, JC5546N

D) JC5378, JC5379, JC7505, JC7534, JC7546, JC7560, JC7562, JC7564,

JC7565, JC7568

E) CM0501, JC2251

F) JC7430, JC7431

G) JC1196, JC1197, JC1198, JC5620, JC5628, JC5630, JC5641

H) JC9944

I) JC6606, JC6612, JC6613

J) JC8612

K) JH8396

L) JC9201

M) JC5408

N) JC5419

O) JC6401, JC6403

P) JC6425

Q) JC6429

R) JC7563

S) JC6421

T) JC6419

U) JC7569

V) JC8401

W) JC8419, JC8428

X) JC6386, JC6502, JC6519, JC6520, JC6546

Y) JC8386, JC8519, JC8537, JC8546

Z) JC7551, JC7552





E) ST10E170, ST10I004



H) ST10E042, ST10I027, ST10I172, ST10J254



K) ST09A269, ST09B225, ST09B312,

ST09C049, ST09C190, ST09K036,


M) ST10C099, ST10J060

N) ST10A405, ST10E004

O) >10 Numbers, Contact Manufacturer

P) >10 Numbers, Contact Manufacturer

Q) >10 Numbers, Contact Manufacturer

R) ST10A158, ST10A325, ST10B256,

ST10E100, ST10F214, ST10H092, ST10I072,

ST10I157, ST10K017

S) ST09A189, ST09E156, ST10G168

T) >10 Numbers, Contact Manufacturer

U) ST10B195, ST10J194

V) >10 Numbers, Contact Manufacturer

W) >10 Numbers, Contact Manufacturer

X) >100 Numbers, Contact Manufacturer

Y) >100 Numbers, Contact Manufacturer

Z) ST10B194, ST10E039, ST10I256

Baxter Corporation has received reports of package brittleness and packaging tearing

easily. Investigation of these reports indicates that the issue may appear after 12 months

and only on some lot numbers.

A) ClearLink System Secondary Medication Set

B) ClearLink Secondary Med Set with Duo-Vent

C) Paediatric Straight Type Blood Set

D) Straight Type Blood Set

E) Y-Type Blood/Solution Set

F) Y-Type Blood/Solution Set with Large Standard Filter

G) Y-Type Blood/Solution Set with Standard Blood Filter

H) InterLink System Y-Type Blood/Solution Set

I) ClearLink Y-Type Blood/Solution with Large Standard

J) ClearLink Y-Type Blood/Solution with Standard Blood

Baxter Corporation 2011-04-18 2011-03-15 62362 Type III A) JC7453

B) JC7462

C) JC7791

D) JC2038, JC7781, JC7790

E) JC7627C

F) JC7724

G) JC7751

H) JC6392, JC6714, JC6720, JC6723

I) JC8723

J) JC8750



C) ST10B047








Baxter Corporation has received reports of package brittleness and packaging tearing

easily. Investigation of these reports indicates that the issue may appear after 12 months

and only on some lot numbers.

Osseotite Certain Implant Biomet 3I,

Also Trading as Implant Innovations, Inc.

2011-04-18 2011-03-11 62560 Type II IOSS413 2009110838 Some implants may have a condition affecting the internal thread. The condition will

prevent the cover screw, temporary healing abutment, final restorative abutment, etc. from

engaging the implant.

Automated Peritoneal Dialysis Sets Baxter Healthcare Corporation 2011-04-18 2011-03-22 62529 Type II 5C4480C, R5C4479C, N5C8305C All lots Baxter is issuing a safety alert to dialysis center clinicians to make them aware of

safeguards that should be considered with seizure prone patients and other at-risk patients

unable to care for themselves due to transient or permanent impairments during

HomeChoice peritoneal dialysis therapy. This follows a reported patient death linked to

tubing entanglement around the neck.

Automated Peritoneal Dialysis Sets Baxter Healthcare Corporation, Renal Division 2011-04-18 2011-03-22 62536 Type II R5C4478, R5C4427 All lots Baxter is issuing a safety alert to dialysis center clinicians to make them aware of

safeguards that should be considered with seizure prone patients and other at-risk patients

unable to care for themselves due to transient or permanent impairments during

HomeChoice peritoneal dialysis therapy. This follows a reported patient death linked to

tubing entanglement around the neck.

Terumo Advanced Perfusion System 1 Terumo Cardiovascular Systems Corporation 2011-04-18 2011-02-23 62534 Type II 801763 0011-0610, 1001-1182 The System 1 circuit breaker is located at the back of the base very close to the floor. Due

to the location and design of the circuit breaker it can be inadvertently tripped by personnel

or other equipment operating in the vicinity of the System 1 base through incidental contact.

O.B.I.S. Salmonella Oxoid Limited 2011-04-18 2011-03-25 62535 Type II ID0570M N/A May produce false negative or weak positive reactions from the NPA test

(nitrophenylalanine).

A) NexGen CKS Quick-Connect Handle

B) NexGn CKS Posterior Referencing Sizer

C) NexGen CKS Postier Referencing Sizer Boom

D) NexGen CKS Modular T-Handle

E) NexGen CKS Distal Femoral Resection

F) NexGen CKS Femoral Valgus Alignment

G) NexGen CKS Extramedullary Distal Telescoping

H) NexGen CKS Extramedullary Proximal Telescoping

I) NexGen CKS Extramedullary Modular Spike

J) NexGen CKS Patella Osteotomy Guide

K) NexGen CKS Patella Clamp

L) NexGen CKS Femoral & Provisional Impactor/Extractor

M) NexGen CKS Patella Peg Drill Guide

Zimmer Inc. 2011-04-18 2011-03-24 62538 Type II A) 00590103400

B) 00590104000

C) 00590104010

D) 00590106100

E) 00590106300

F) 00590106700

G) 00590107100

H) 00590107200

I) 00590107400

J) 00590301000

K) 00590302000

L) 00590102600

M) 00590306000

A) 61612789, 61682485, 61550601

B) 61558673, 61610687

C) 61558201

D) 61517185, 61609572

E) 61548704, 61615895

F) 61559529, 61625078

G) 61559187, 61633778

H) 61543636

I) 61549223, 61593951

J) 61559367

K) 61555948, 61635432

L) 61522231, 61550613, 61637191, 61657309,

61659596

M) 61511575, 61542246, 61630733

Zimmer is initiating a recall of certain lots of NexGen Complete Knee Solution (CKS)

posterior referencing instruments (PRI) because they have a potential for exhibiting a

breakdown of the aluminum/titanium nitride PVD black coating. The NexGen PRI utilize this

coating as a cosmetic means to depict points of attachment or adjustment of the

instruments.

NexGen CKS Femoral & Provisional Impactor/Extractor Zimmer Inc. 2011-04-18 2011-03-24 62540 Type II 00590102600 61522231, 61550613, 61637191, 61657309,

61659596

There is a potential for the spring clip of the NexGen Complete Knee Solution Femoral and

Provisional Impactor/Extractor to break off during use and fall into the surgical site. Zimmer

has received 24 complaints of the spring clip breaking, 4 of which were reported that the

patient had to undergo additional x-ray to ensure the fractured clip had not been left in-vivo.

There has been 1 report of the spring clip being found in-vivo during this process. These

instruments (same lots) are already being recalled in relation to another issue (black coating

falling off) - see recall number 62538.

A) Artiste MV-Linear Accelerator-Syngo RT Therapist Assist

B) Artiste MV-Linear Accelerator-Syngo RT Therapist


B) 08162815

A) 10024, 10048

B) 10003, 10040

There is a potential safety risk related to patient treatment when using the portal review

application of the Syngo RT Therapist. As a consequence of this risk, an incorrect offset

may be applied for patient positioning and thus may result in a mistreatment (dose to wrong

location).

Aequalis Fracture Stem Implant Tornier 2011-04-18 2011-02-15 62613 Type II DWB171, DWB172, DWB173 3566AJXXX, 4720AJXXX, 4721AJXXX,

4722AJXXX, 5346AJXXX,

2793AJXXX

Mislabeled product. Inner and outer label of some lots labelled 'cementless' instead of 'for

cemented use only.'

Lap-Band Access Port Needles Allergan, Inc. 2011-04-18 2011-03-21 62572 Type II B-20302-10 9L01N A small number of access port needle accessory pouches from lot 9L01N may have a

breach in seal integrity (voids across seal) that may result in the products no longer being

sterile.

A) Unicel DXI 600 Access Immunoassay System - Instrument

Class 2

B) Unicel DXC 880I Synchron Access Clinical Analyzer

C) Unicel DXI 800 Access Immunoassay System - Analyzer

Class II

D) Unicel DXC 660I Synchron Access Clinical Analyzer

E) Unicel DXC 860I Synchron Access Clinical Analyzer

F) Unicel DXI 600 Access Immunoassay System - Instrument

with Dual Gantry Class 2

Beckman Coulter, Inc. 2011-05-02 2011-01-26 61295 Type II A) A30260

B) 4768

C) 973100

D) 4771

E) 4773

F) A71461

A) A30260

B) A59102

C) 973100

D) A64871

E) A64935

F) A71461

The sample presentation unit ("SPU") may push two sample racks instead of one into the

sample presentation area when the gap between racks is obstructed with foreign material

such as tape. Beckman Coulter has received a report of results that were associated with

incorrect patient identifications when two sample racks advanced into the sample

presentation area in one push. The first rack of the two was not scanned. This is referred to

as a "pushed pair."

iSite PACS Philips Healthcare Informatics, Inc. 2011-05-02 2011-03-23 62475 Type II Version 3.X N/A When performing measurements on a volume value image (MIP, MPR, 3D), clinicians are

able to take snapshots of their measurements in a capture window. If they do not save the

capture window and they make measurement changes in the original image, it updates the

measurement values in the capture window, but it does not update the associated graphics

in the capture window. Thus, the measurement value no longer corresponds to the graphic

displayed in the capture window. This could lead to an incorrect interpretation of the

measurements which could cause an incorrect diagnosis and incorrect treatment plan.

IMPAX CV - Cardiovascular Review Station (CRS) Agfa HealthCare 2011-05-02 2011-03-21 62606 Type II 60+00007791 N/A If the end user does not follow Agfa's recommended XA measurement calibration technique,

the resulting calibration may result in an imprecise XA measurement being obtained.

A) Bigliani/Flatow Shoulder IM Reamers

B) TM Shoulder Instrument Distal Pilot


Zimmer Inc. 2011-05-02 2010-09-17 56687 Type II A) 00430100600, 00430100700, 00430100800, 00430100900, 00430101000,

00430101100, 00430101200, 00430101300, 00430101400, 00430101500,

00430101600, 00-4301-006/016-00, 00-4301-000-17/18

B) 00431000813, 00431000817, 00431000913, 00431001013, 00431001017,

00431001113, 00431001213, 00431001217, 00431001313, 00431001413,

00431001417, 00431001513, 00431001613, 00431001713, 00431001813



The distal reamers described are only affected by this recall when used with the Trabecular

Metal Humeral and the Trabecular Metal Reverse Shoulder Systems. A Zimmer complaint

investigation of these two systems suggests that surgeons may find that the trial stem fits

appropriately, but the implant engages the humeral canal earlier than expected. As part of

a Recall Update to customers, issued on March 29 2011, Zimmer notified customers

of an error in the affected item numbers for the Distal Reamers provided in the

previous communication ? They should have been identified as "00-4301-006/016-00

and 00-4301-000-17/18. " Integrated Reusable Fibre Optic Blade BOMImed Inc. 2011-05-02 2010-11-04 58635 Type II OL-32D0, OL-32D1, OL-32D2, OL-32D3,

OL-32D4, OL-32E0, OL-32E00, OL-32E1,

OL-32E2, OL-32E3, OL-32E4

0310, 0510, 2710, 3210 There is a potential issue with an aesthetic dot at the back of the blade. Potential for this

dot to become loose or fall out after autoclave. This could occur on about 10% of all

manufactured blades. May pose potential risk if not monitored.

A) Non-DEHP Microbore Administration Set

B) Microbore Administration Set

C) Epidural Administration Set

Zevex Inc. Also trading as Moog Medical Devices Group 2011-05-02 2011-01-27 61461 Type II A) 340-4168

B) 340-4115, 340-4134

C) 340-4126

A) D100712

B) D004616, D008511, D010911

C) D010321, D010416, D013714, D015326,

CF10120003, D016002, D017913

A defect with the resin used in tubing received from a supplier has been discovered. This

has resulted in a rough texture on the inner and outer diameter of the tubing segment

inserted into the pump. This could lead to the pump sensor registering an air bubble,

causing an unresolvable false air-in-line alarm, even if no air bubble is present.

Visage 7 Software Visage Imaging GMBH 2011-05-02 2010-12-15 61551 Type II Visage 7.0X 35300083 During quality control and improvement process for Visage 7 software, two of specialized

2D measurement tools in some situations do not allow for manual pixel calibration and can

lead to misleading results.

35A Series Ambulance Stretcher Ferno, Division of Ferno-Washington, Inc. 2011-05-02 2011-03-07 62159 Type III N/A N/A Labels display incorrect load limit of 273 kg (600 pounds) instead of the intended limit of

227 kg (500 pounds).

IFU for Inflow/Outflow Cannula Stryker Endoscopy 2011-05-02 2011-03-08 62215 Type II 0747-031-650 All lots Stryker Endoscopy has discovered that the cleaning validation adoption for the

inflow/outflow cannula was not effective at cleaning.

MLX 300 Watt Xenon Light Source Integra Radionics, Inc. 2011-05-02 2011-03-10 62480 Type II 00MLX N/A There is a potential malfunction of the MLX control board attributed to an over riding jumper-

wire on repaired 300 watt power supply, which may not have been removed during repairs

requiring a new replacement power supply.

Optimal-IT:Con-Zellin Disinfecting Swabs in Indivdual Test Kits Bio-Rad 2011-05-02 2011-03-29 62619 Type II 710024 0B0010, 0C0011M, 0E0016M, 0G0021M,

0J0026M, 0K0029M, 0K0030M

Certain lots of Con-Zellin Disinfecting Swabs included in individual Optimal-IT Kits could be

contaminated with the bacillus cereus bacteria.

A) Micrus Endovascular Microcoil System -Presidio Microcoil

PC4

B) Micrus Endovascular Microcoil System-Cashmere Model

SRC

C) Micrus Endovascular Microcoil System-Cashmere Model

CRC

D) Micrus Endovascular Microcoil System-Deltapaq-10 SR

E) Micrus Endovascular Microcoil System-Deltapaq-10

Cerecyte

F) Micrus Endovascular Microcoil System-Modified Cerecyte

Microcoil - CSP

G) Micrus Endovascular Microcoil System-Deltaplush 10

Cerecyte

H) Micrus Endovascular Microcoil System- Deltaplush 10

Stretch-Resistant

I) Micrus Endovascular Microcoil System-Micrusphere XL 18

Stretch-Resistant

Micrus Endovascular Corporation 2011-05-02 2010-10-25 58338 Type II A) PC4100412-30, PC4100626-30, PC4100730-30, PC4180830-30, PC4180933-

30, PC4181137-30, PC4181240-30

B) SRC140303-20, SRC140306-20, SRC140408-20, SRC140615-20, SRC140717-

20, SRC140922-20

C) CRC140306-30

D) DFS100152-20, DFS100154-20, DFS100156-20, DFS100203-20, DFS100204-

20, DFS100250-20, DFS100254-20, DFS100306-20, DFS100308-20, DFS100310-

20, DFS100408-20, DFS100410-20, DFS100510-20, DFS100616-20, DFS100716-

20, DFS100925-20, DFS101025-20

E) CSP100300-30, CSP100400-30

F) CPL100151-30, CPL100254-30, CPL100306-30

G) DPL100152-20, DPL100153-20, DPL100201-20, DPL100203-20, DPL100204-

20, DPL100206-20, DPL100254-20, DPL100256-20, DPL100304-20, DPL100306-

20, DPL100408-20

H) DPL100152-20, DPL100153-20, DPL100201-20, DPL100203-20, DPL100204-

20, DPL100206-20, DPL100254-20, DPL100256-20, DPL100304-20, DPL100306-

20, DPL100408-20

I) SSR180825-20, SSR181028-20, SSR181128-20, SSR181540-20, SSR181640-

20, SSR181740-20

A) f62328, g11109, g11154, g11102, g11131,

g11140, g11106


C) g10996, g11310


E) g10987

F) g11062, g11180

G) g11053, g10962


I) g11090, g11087, g11093, g11088, g11094,

g11326

Dimensional issues associated with the connector hub that is used to attach the device

positioning unit to the detachment control cable. Loss of electrical conductivity can result in

failure to detach a coil for deployment inside an aneurysm.

Marus Link Arm Assembly Dental Equipment, LLC 2011-05-02 2011-03-07 62578 Type III N/A Catatalogue numbers DC1690, DC1700,

DC1702, DC1235, DC1490

The link arm assembly that connects some rear mounted accessories such as cuspidors and

assistant's instrumentation to the DC1235, DC1490, DC1690, DC1700 and DC1702 dental

chair models may break and fall off the dental chair.

Zest Locator Abutment Pitt Easy 3.75mm Zest Anchors, LLC Also trading as Zest Anchors, Inc. and

Zest Anchors

2011-05-02 2010-11-20 59635 Type III 08323P 96485, 97325 Outer label of Pitt Easy 3.75 mm diameter implants were correctly labelled as 3.0 mm

locator abutment, however inner bag was incorrectly labelled as 2.0 mm locator abutment.

Correct Quick Extra Light Pentron Clinical Technologies, LLC 2011-05-02 2011-02-20 61879 Type III N/A 197937 Four complaints that dental impression material set too quickly.

Therakos UVAR XTS Procedural Kits Therakos, Inc. 2011-05-02 2011-04-04 62673 Type II XT001, XT125 >10 Numbers, Contact Manufacturer Therakos has received an increased rate of complaints related to leaks at tubing

connections for certain lots of Therakos UVAR XTS Procedural Kits. Internal investigation

has determined that a raw material used in the manufacture of the kit is causing leaks to

occur in certain lots.

A) Cirrus HD-OCT

B) Cirrus HD-OCT Model 400

Carl Zeiss Meditec Inc. 2011-05-02 2011-03-14 62637 Type III A) 4000

B) Model 400

A) N/A

B) N/A

When following a specific workflow in which operators (1) acquire data, (2) log out without

analysing the data, and (3) log back in and acquire data for another patient, the exam data

from the second patient may incorrectly be saved under the name of the first patient.

A) J-VAC Reservoir

B) Blake Drain Kit

C) Flat Blake Silicone Drains 3/4 Fluted without Trocar

D) Flat Blake Silicone Drains 3/4 Full Fluted without Trocar

E) Flat Blake Silicone Drains Full Flued with Trocar

F) Flat Blake Silicone Drains 3/4 Fluted with Trocar

G) Round Blake Hubless Silicone Drains without Trocar

H) Round Blake Hubless Silicone Drains with Trocar

I) Blake Cardio Connector

Ethicon Inc. 2011-05-02 2011-04-05 62679 Type II A) 2160

B) 2207, 2236, 2238

C) 2210, 2213

D) 2211, 2214

E) 2212

F) 2216, 2217

G) 2226, 2228, 2230, 2234

H) 2227, 2229, 2231, 2232, 2233

I) BCC1, BCC2, BCC3

A) J100214, J100720, J101307, W00024418,

W00025494

B) J103604, J101046, J101047, J103586,

J100440, J103590

C) W00025507, J100174, J100011, J101607,

J108130, J100140, J101503, J102391

D) J100665, J100079, J100080, J100672,

J101527, J1015775, J102897, J103976,

W00025526

E) J101270

F) J100010, J101249, J101511, J100183,

J101518, J104968, J108182, J108183,

W00024310




Ethicon, Inc. is recalling multiple lots of Blake Drains, Blake Drain Kits, Blake Drains with

Trocar, Blake Cardio Connectors, and J-VAC Reservoirs, with distribution dates of May 10,

2010 to present. The company has identified the potential for the sterile barrier of the

product packaging to be compromised after receiving customer complaints.

Process System Manager (PSM) Software Roche Diagnostics Ltd. 2011-05-02 2011-04-04 62746 Type I 04944607001 All lots Result mix up that can occur when sample IDS (barcode number/tube identifier) are

repeated in the Process System Manager (PSM) database and results are manually resent

to the hospital host system (laboratory information system (LIS)).

Spacelabs Medical Patient Monitor, 91387 Spacelabs Medical, Inc. 2011-05-02 2011-04-11 62752 Type II 91387 >100 Numbers, Contact Manufacturer The manufacturer has determined through internal testing that the circuit that supplies

backup power to the modules is not working. If there is a power interruption, the 3-minute

backup may not be operational and you may lose any changes you have made to the alarm

settings. When used with model 91387, the hazard presents a risk for all modules except

modules 90470, 90478, 90496 & 91496, all of which have their own internal backup and will

not lose changes to the alarm settings for power interruptions less than 3 minutes.

Arterial Blood Gas Sampling Kit Westmed, Inc. 2011-05-02 2011-01-03 62597 Type I 3373, 3373-95 N/A This recall has been initiated due to product containing Triad alcohol and iodine pads. Triad

Group is reporting a potential contaminant in the alcohol and iodine pad that can possibly

cause a rash or skin infection.

A) Vitaline H Set Infant/Neonatal 25UN

B) Filterline H Set Infant/Neonatal

Oridion Medical 1987 Ltd. 2011-05-02 2011-03-25 62748 Type II A) 010807

B) 006324

A) M8535B11

B) M8544B11

During incoming inspection of the Filterline H Set Infant Neonatal CO2 sampling line by a

distributor, plastic strands with a typical length of 0.5 cm and a diameter of 100 microns

were found on the inner side of the adapter.

Urethral Procedure Tray With Syringe Teleflex Medical 2011-05-02 2011-04-06 62758 Type II 67890, 68895 >10 Numbers, Contact Manufacturer This recall supersedes Teleflex's March 4, 2011 communication. Teleflex Medical is

withdrawing the Rusch Irrigation Trays catalogue number 67890 and 68895 from the

market. These trays contain alcohol prep pads recalled by Triad due to concern about

bacterial contamination. All trays containing the alcohol prep pads recalled by Triad should

be returned to Teleflex Medical.

enGen Laboratory Automation Systems Thermo Fisher Scientific OY 2011-05-02 2011-04-08 62760 Type III enGen JCT20Q3J, J16XQH4J, JIHX7S4J, J41BCY4J Ortho Clinical Diagnostics (OCD) has determined that some dilution factors configured on

the enGen Laboratory Automation System are not supported in the instructions for use for

the following 4 OCD Vitros Products: Vitros CHE Slides, Vitros CRBM Slides, Vitros TIBC

Kit, and Vitros UPRO Slides. To address this, OCD will implement a software modification

that will remove all non-supported dilution factors on the enGen System.

A) Sprint Fidelis Steroid Eluting Quadripolar Vent.

B) Sprint Fidelis Steroid Eluting Tripolar Vent.

C) Sprint Fidelis Steroid Eluting - Quadripolar

D) Sprint Fidelis Steroid Eluting - Tripolar

Medtronic Inc. 2011-05-02 2011-04-01 62706 Type III A) 6949

B) 6931

C) 6948

D) 6930




D) LFK004993V, LFK004820V, LFK004984V,

LFK005530V, LFK001689V, LFK003047V,

LFK001690V, LFK004992V

It is no longer a recommended option to implant a pace-sense lead while maintaining use of

the Fidelis high voltage conductors after a Fidelis pace-sense conductor fracture has

occurred.

A) Sprint Quattro Secure S Ventricular Lead

B) Sprint Quattro Secure Quadripolar Lead

Medtronic Inc. 2011-05-02 2010-10-26 59071 Type II A) 6935

B) 6947



Possible over-retraction of the helix beyond the retraction stop could occur, which may

result in the inability of the helix to extend in subsequent attempts.

Adult R2 Non-Radiolucent Electrodes Conmed Corporation 2011-05-02 2011-03-31 62596 Type II 3200-1715 1010194 Catalogue number 3200-1715, lot 1010194, were assembled without the white oval shield

which covers the wire set's rivet connection to the electrode pad. If the white rivet cover is

missing, the metal rivet is exposed.

A) VITEK 2 Compact 30 System

B) VITEK 2 Compact 60 System

C) Vitek 2 / Susceptibility test Cards

bioMerieux, Inc. 2011-05-02 2011-04-04 62767 Type II A) 22214, 22224, 22225, 22227, 22228, 22229, 22230, 22244, 22245, 22246,

22250, 22293, 22295, 410101, 410102

B) 22214, 22224, 22225, 22227, 22228, 22229, 22230, 22244, 22245, 22246,

22250, 22293, 22295, 410101, 410102

C) 22214, 22224, 22225, 22227, 22228, 22229, 22230, 22244, 22245, 22246,

22250, 22293, 22295, 410101, 410102

A) All lots

B) All lots

C) All lots

bioMerieux distributed a product correction notice in September 2010 regarding the

performance of piperacillin/tazobactam (TZP) with E.coli and K.pneumoniae on the Vitek 2

gram negative susceptibility test cards. Further performance testings revealed overcalling

resistance issues for additional species. These species include, E.coli, K. pneumoniae, M.

morganii, P. mirabilis, P. vulgaris, P. rettgeri, P. stuartii, P. aeruginosa, S. enterica.

Capture-CMV Indicator Red Cells Immucor Inc. 2011-05-02 2011-04-11 62791 Type II 0062791 228143 The indicator cells of this lot continue to show acceptable reactivity when used for testing

according to the package insert, however, weaker reactions have been observed with the

Capture-CMV positive control serum (weak).

Ca++ membrane code 942-060 Radiometer Medical ApS 2011-05-02 2011-04-07 62795 Type II 942-060 All lots Since September 2010. Wrinkles in Ca++ membrane unit foils can cause biassed measuring results.

A) Diagnost 97

B) Diagnost 94

Philips Medical Systems Nederland B.V. 2011-05-02 2011-04-04 62796 Type II A) MII 3061, MRC 0651

B) 70850, 70851

A) N/A

B) N/A

During examination, if the patient is positioned with his knees pointed to the rear of the

system and the operator performs a wrong movement of the scanning beam, downwards

instead of upwards, the leg(s) of the patient might collide with the stand and get squeezed,

potentially resulting in a (serious) injury.

Intellivue-Information Center Philips Medical Systems 2011-05-02 2011-04-04 62798 Type II M3150, M3155 N/A There is a potential for early component failure. The system board in the Hewlett-Packard

RP5700 computer contains electrolytic capacitors that may fail prematurely, causing the

computer to malfunction. It is also possible that the display may "freeze".

Intellivue-Information Center Philips Medical Systems 2011-05-02 2011-04-04 62799 Type II M3150, M3155 N/A Philips has become aware that some PAS-210 active speaker assemblies in use with the

Philips Intellivue Information Center (PIIC) have experienced intermittent audio or loss of

audio. After investigation, it was determined that the speaker failures may delay recognition

of an alarm condition, if operators do not recognize that there is no alarm sound from the

monitor and the monitor is not connected to another audible alarm annunciation system,

e.g., a bedside monitor. This may result in delayed treatment of the patient.

A) Xeleris 2 Workstation Imaging System

B) Xeleris Nuclear Medicine Workstation

GE Medical Systems Israel, Functional Imaging 2011-05-02 2011-01-11 56796 Type III A) H3900JH, H3900NM, S8006KA/KB/KC/KD

B) H3700JA/JB/KA/KB



The Xeleris thyroid uptake index operator manual seems to be inadequate since customers

are confused about the correct procedures or not performing it correctly, including not using

the calibration factor.

Intellivue Clinical Information Portfolio Philips Medizin Systeme Boeblingen GMBH 2011-05-02 2011-04-04 62797 Type II Intellivue Clinical Information Portfolio All lots Under certain circumstances, edits to an order can result in unintended scheduled

interventions on the Intellivue Clinical Information Portfolio. If the clinical team does not

recognize that extra scheduled interventions exist, a patient may receive interventions or

additional medication doses that are not intended.

Nanolight MP50 Sybaritic Inc. Global Aesthetic Solutions 2011-05-02 2011-03-08 62866 Type II 404208-MP, 404208-MPG All lots Unlicensed class III device - notification to distributors.

OneTouch Zoom Pro Diabetes Management Software Version

5.1

LifeScan Inc. 2011-05-02 2011-04-18 62887 Type III 022-151 A-58277 OneTouch Zoom Pro Diabetes Management Software has an incompatibility issue with

Microsoft MSXML4 service pack 1. When this program interfaces with OneTouch Zoom Pro

Diabetes Management Software it can cause device blood-glucose values under specific

circumstances, to be displayed in numbers that are significantly higher than their true

mmol/l values.

OptiBond Adhesive Refill Kerr Corporation 2011-05-02 2011-03-16 61848 Type II 25882 3447051 There is one mislabeled lot of this product. Some of the refill bags of the OptiBond FL

Adhesive contained the OptiBond FL Primer bottle.

Microbore Administration Set Baxa Corporation 2011-05-02 2010-10-15 62929 Type III N/A All lots till October, 7 2010. Microfuge Administration Sets sold without medical device license prior to October 7, 2010.

A) Bio-Console Drive Unit (550)

B) Autolog Autotransfusion System

C) Bio-Console Drive Unit (560)

D) Magellan Autologous Platelet Separator

Medtronic Inc. 2011-05-02 2010-04-28 54391 Type II A) 95208

B) ATLG110

C) 560

D) MAG100

A) 8473, 8466, 8687, 8607, 8729, 8622, 8184,

8677



D) MAG1001017, MAG1000592, MAG1000043,

MAG1000506, MAG1000249, MAG1000644,

MAG1000019, MAG1000597, MAG1000594

Possibility of sparking, charring & fires from the power cords because the power cord's

prongs may crack & fail at/or inside the plug.

Aria Software (Version 6.5) Varian Medical Systems, Inc. 2011-05-16 2011-02-18 62920 Type II Vision (Version 6.5) HIT0040, HIT0606M, HIT0606RI, HIT0716 An anomaly was identified in the Aria Versions 8.0 and 8.1, when an image sequence

template is added to a field in RT chart and a CIAO (completely irradiated aperture opening)

is calculated, the resulting CIAO display at 4DITC may be wrong. This results in a CIAO

which is in many cases larger than the actual largest extent of the irradiated area - possibly

leading to an unintentional gap if that outline is used for edge matching of a second field.

Soft-Core Classic Endodontic Obturator Ormco Corporation,

Also trading as Sybronendo

2011-05-16 2011-03-14 61830 Type III ESC-03006CL 081006701 The Soft-Core Endodontic Obturator procedure packs contained a size #25 obturator rather

than the correct size #30 obturator.

Signa HDE 1.5T MRI System - Magnet GE Healthcare Japan Corporation 2011-05-16 2010-12-15 56973 Type II M3335SE All Serial Numbers Potential for failure for users to provide an obstacle free service path outside the 200g field

& not having another trained person on site, resulting in death or serious injury to service

engineers.

Signa HDE 1.5T MRI System - Magnet GE Healthcare Japan Corporation 2011-05-16 2010-12-15 57846 Type II M3335SE All Serial Numbers If gradient cables are inadvertently swapped while servicing and geometry check not

performed as required in procedure, images may be flipped left-right with incorrect

orientation annotation.

SPoT-Light HER2 CISH Kit Invitrogen Corporation 2011-05-16 2011-04-18 62851 Type III 84-0150 849398A The identified lot of SPoT-Light HER2 CISH Kit includes SSC buffer that may be

contaminated with acremonium strictum, a fungal contaminant. This incident was identified

through a customer complaint. This customer also reported a weaker staining, however, in-

house testing of the buffer with the kit indicated that the kit continues to perform as intended.

Comprehensive Primary & Fracture Shoulder Stem

Inserter

Biomet Orthopedics 2011-05-16 2011-04-07 62868 Type II 31-406901, 407398 525360, 293840, 299010, 401810 When attempting to remove inserter from the stem, the inserter may become stuck, not

allowing it to disengage from the stem.

Vitros 5600 Integrated System Ortho-Clinical Diagnostics Inc. 2011-05-16 2011-04-14 62869 Type III 680 2863, 680 2864 56000124, 56001005 Ortho Clinical Diagnostics received a customer complaint regarding the loss of calibration

data following the installation of a development-only assay data disk (ADD), data release

version (DRV) 9241 or 9251, that was available in the on-screen mailbox on the main menu

system status screen of their Vitros 5600 Integrated System.

A) Dash 3000 Patient Monitor

B) Dash 5000 Patient Monitor

C) Dash 4000 Patient Monitor

GE Medical Systems Information Technologies,

Inc.

2011-05-16 2011-04-21 62636 Type II A) DASH3-XXXX-XXXX-XXXX

B) DASH5-XXXX-XXXX-XXXX

C) DASH4-XXXX-XXXX-XXXX




Dash Monitor may show reboots on some networks when 802.11B wireless LAN option used

to connect to hospital wireless LAN infrastructure, resulting in loss of patient monitoring,

patient alarms & vital signs data.

RealSeal .02 Taper Points Ormco Corporation, Also trading as Sybronendo 2011-05-16 2011-02-21 61845 Type III 972-2235 190901 Labelling error. Box is labelled 972-2435, .04 taper points, but outer bag is labelled 972-

2235, .02 taper points. Actual contents are 972-2235.


B) Clinac IX High Energy Linear Accelerator

C) Trilogy High Energy Linear Accelerator

D) Novalis TX High Energy Linear Accelerator

E) Clinac 2100C High Energy Linear Accelerator

F) Clinac 21EX High Energy Linear Accelerator

G) Clinac 23EX High Energy Linear Accelerator

Varian Medical Systems, Inc. 2011-05-16 2011-03-17 63079 Type II A) 600C, 6EX

B) Clinac IX

C) Trilogy

D) Novalis TX

E) 2100C

F) 21EX

G) 23EX

A) H180796 (6EX Unit), H180605 (600C Unit),

H180600 (600C Unit), H291180 (600C Unit),

H293787 (600C Unit), H272910 (6EX unit),

H180619 (6EX Unit), H180683 (6EX Unit)


C) H272158, H272283, H180601, H293908,

H293509

D) H272857

E) H272118, H271662, H271663, H272858


G) H291172

Collimator cover is falling from the linear accelerator. It appears the collimator cover was

not properly installed and that motion of the linear accelerator caused the cover to detach

and fall from the machine. It was determined that the collimator latching mechanism may

be difficult to latch properly, resulting in an increased likelihood of accidental detachment of

the collimator cover.

TMA Archwires Ormco Corporation,

Also trading as Sybron Implant Solutions

2011-05-16 2011-04-26 63143 Type III 211-1402 10k291 Mispackaging of TMA Archwires. Packages labelled with 211-1402 (TMA broad arch .016 x

.022 lower) actually contained 202-1007 (TMA upper arch .017 x.025)

Artiste Nano-Hybrid Flowable Composite Pentron Clinical Technologies, LLC 2011-05-16 2011-04-20 63139 Type III N28F, N28VF, N28VXA 166859, 172112, 179105, 185567, 174980 Artiste Flowable is difficult to extrude. Production records confirmed that product was

released out of specification for viscosity. Additional lots added to initial recall.

Colleague Volumetric Infusion Pump Baxter Healthcare Corporation 2011-05-16 2011-04-14 63119 Type II DNM9161 20110002JF, 20110004JF, 20110005JF,

20110007JF, 20110010JF, 20110001JF

Baxter has determined that there is a potential soldering defect with a single component

identified on a limited number of UIM PCBA (user interface module printed circuit board

assembly) received from their PCBA supplier/manufacturer. This issue is limited to the

Colleague Pump serial numbers listed. This soldering defect could lead to a delay or

interruption of therapy.

Flow Set Fluorosphere Beckman Coulter, Inc. 2011-05-16 2011-04-25 63160 Type II 6607007 7524013F Beckman Coulter has identified that Flow-Set Fluorospheres, part number 6607007, lot

7524013f, table of application target settings sheet has mislabeled target values for

stemONE and stemCXP.

Solution packs to ABL80 Basic/Flex Radiometer Medical APS 2011-05-16 2011-04-18 63213 Type III 944-174, 944-309 62718, 62784, 62871, 63038, 63134, 63390,

63480, 63620, 63718,

63864, 62785

Affected lots of Solution packs were produced with a wrong conductivity value encoded into

the chip. This causes a minor negative bias for the HCT (hematocrite) measurement of 1 to

2% and following failure of the air detection system.

TEG 5000 Hemostatis Analyzer Haemonetics Corporation

DBA Haemoscope Corporation

2011-05-30 2011-01-24 62582 Type III 5000 All lots Letter to customers advising on proper connection and handling of the power source after a

product complaint. If the DIN4 connector is removed before removing the power supply

from the electrical outlet and if the DIN4 connector made contact with metal, the unit will

heat and smoke. The thermal fuse would open however to mitigate any risk.

ARTISTE, ONCOR with 160-MLC Siemens AG 2011-05-30 2011-04-19 63083 Type III 8139789 5414, 5485 Potential safety risk related to the behaviour of the 160 mlc when using the 'motion stop'

button followed by `reset' several times during the treatment of one beam or one segment.

As a consequence of this mlc behaviour, the leaf positions may vary from the originally

prescribed position. Therefore the remaining MU for the beam or segment may be applied

to an incorrect field size and thus could result in a mistreatment (dose to wrong location).

ReticPrep Reagent Kit Beckman Coulter, Inc. 2011-05-30 2011-04-08 63103 Type II 7546978 108901K Coulter ReticPrep Reagent Kit, PN 7546978, lN 108901K components were packaged into

an undetermined quantity of cartons labelled as lN 108900K.

COULTER Ac T 5diff Fix Reagent Beckman Coulter, Inc. 2011-05-30 2011-04-11 62846 Type II N/A 16602E, 16702E, 16802E Beckman Coulter Inc. identified an issue with one of the raw materials used to manufacture

the COULTER Ac T 5diff Fix Reagent, lots: 16602E, 16702E, and 16802E. .

A) Viridia Component Monitoring System

B) Filterline Set H Infant / Neonatal

C) Intellivue MP30 Patient Monitor System-Microstream Co2

Extension

D) Intellivue MX800 Patient Monitor System-Microstream Co2

Extension

Philips Medizin Systeme Boeblingen GMBH 2011-05-30 2011-04-13 63014 Type II A) M1923A

B) 9898031 59581

C) M3015A

D) M3015A

A) N/A

B) N/A

C) N/A

D) N/A

It was determined that fine plastic strands inside the endotracheal tube side of the airway

adapter may become dislodged and subsequently inhaled by the patient. The strands are

typically 5mm long and 100 microns in diameter, about the thickness of a human hair.

Total Iron Binding Capacity (TIBC) Assay Siemens Healthcare Diagnostics Ltd. 2011-05-30 2011-04-15 63097 Type III 3940010 V43197 The Advia Chemisty Systems 1200, 1650, 1800 and 2400 TIBC Reagent (lot V43197) was

mislabeled with an expiration date of 18 months that exceeds the true expiration date of 12

months.

Zenith AAA Endovascular Graft Cook, Inc. 2011-05-30 2011-04-20 63110 Type II TFLE-10-71-ZT 2696926 One lot number is being recalled in Canada due to the receipt of information that indicates

there may be potential damage to the braided suture which is used to attach the external

stent to the graft material.

IMMAGE 800 Immunochemistry System Beckman Coulter, Inc. 2011-05-30 2011-04-25 63125 Type II A15445 >10 Numbers, Contact Manufacturer The catalogue number (cat no) listing on the IMMAGE 800 name rating plate label is

incorrect for units with serial numbers: 9081 - 9171, 9176 - 9178. The cat no should be

A15445, but is listed as A15455 because of a typographical error. All information on the

label other than the cat no is correct.

Waters IEEE Detector Waters Corporation 2011-05-30 2011-03-25 63353 Type III 2487 C06487243M, M06487017M Potential exists for some data points within the 2D chromatogram to be missing due to

signal dropout. This is evident with the Waters IEEE Detector and associated Empower

software.

BiteProof Bite Blocks, Part #11040 B & B Medical Technologies 2011-05-30 2010-03-31 55384 Type II Part #11040 D816804 The plastic arm that connects the sticky tab to the bite block itself has a thin area of plastic

just where the bite block connects. The bite block separated from the sticky tab at this

thinner area.

ReliaMed Deluxe Portable Adjusting Table Huangshan City Shexian Comfort Massage Appliance

Company Ltd.

2011-05-30 2010-04-23 59698 Type II ZZRMT100BL (Blue), ZZRMT100BLK (Black) N/A MDC has received 3 complaints involving table breakage during use. Each complaint

involved reports of breakage of the vinyl-covered, padded, plywood table surface near the

foot end. No actual injury occurred in any of the complaints.

Oxygen Sensor/R-15 Teledyne Instruments, Analytical Instruments 2011-05-30 2010-12-07 60029 Type II R-15 617654, 617655, 617656 American customers discovered electrolyte breach resulting in discolouring of sensor on

class R15 oxygen sensors. Company investigation revealed some sensors had a deeper

and slanted chamfer on the sealing cylinder hole that may have resulted in compromised

sensor seal.

A) Dual Blue-Release Adult Walker-Wheeled

B) Blue Release Junior Walker with 5" Fixed Wheels

Invacare Corporation 2011-05-30 2011-03-25 62607 Type II A) 6240-5F

B) 6240-JR5F

A) HP XXXXXX

B) HP XXXXXX

This product is being recalled because the caster bolt on the wheeled extension is too short

to adequately maintain the nylex fastener, resulting in potential caster loosening and

increased likelihood of the caster falling off of the walker. This has the potential to create

unexpected user instability.

Unicel DXH 800 Coulter Cellular Analysis System Beckman Coulter, Inc. 2011-05-30 2011-04-11 63028 Type II 629029 All lots / Tous les lots Beckman Coulter has the following issues with the Unicel DXH 800 Coulter Cellular Analysis

System:

1.Auto prune will not remove patient results if the patient record includes demographics

where the results are less than 30 days old.

2.The last set of results for each panel analyzed without demographics will always be saved.

3.The DXH 800 may intermittently fail to transmit the correct control files, or partially

transmit the number of control files requested, to the interlaboratory quality assurance

program ("IQAP") through the remote management system (RMS).

4.The DXH 800 exports control data intended for interlaboratory quality assurance (IQAP) in

the reporting units configured by the customer. IQAP is expecting to receive those results in

one standard format.

ACCESS HAV Ab Beckman Coulter, Inc. 2011-05-30 2011-03-29 63094 Type II 34200 94059, 94060 The ACCESS HAV Ab assay of product lot exhibits inconsistent patient dose response. This

inconsistency may be manifested by erroneously low or high QC/sample dose results that

could cause incorrect qualitative classification (i.e. false positive, false negative, false

equivocal results) for the patient.

Tempus IC Patient Monitor Remote Diagnostic Technologies Limited 2011-05-30 2011-03-22 63234 Type III 00-1001 000418, 000443, 000467 If a 12 lead ECG is recorded and the user restarts ECG monitoring quickly (e.g. if the

recorded ECG is viewed for less than 13 seconds) then the ECG can cease operating. This

issue can present itself either as a monitoring view with no ECG lead traces shown on the

display of (more likely) as a leads-off condition on all leads in monitoring mode. In this case

ECG monitoring is suspended.

Zoll E Series BLS Defibrillator Zoll Medical Corporation 2011-05-30 2011-04-21 63242 Type II Zoll E Series Software Version 7.10 of 7.11 We have identified an unusual condition under which the E Series BLS Defibrillator can

display a shock advised message but not auto-charge the defibrillator. Failure to auto-

charge the defibrillator could delay delivery of therapy.

Liquichek Hematology 16 Control

(Low, Normal & High)

Bio-Rad Laboratories 2011-05-30 2011-04-19 63257 Type II 760, 761, 762, 763 76771, 76772, 76773, 76770 Boxes of Liquichek Hematology 16 Control (Low, Normal and High) master lot 76770 may

contain vials of Liquichek Hematology 16 Control (Low, Normal and High) master lot 76760.

A) Ultra Zone 3 Air Mattress

B) Ultracare 10 Air Mattress

T.H.E. Medical 2011-05-30 2011-04-20 63320 Type III A) TD1002

B) TD1004

A) N/A

B) N/A

Unlicensed device sold.

enGen Laboratory Automation Systems Thermo Fisher Scientific OY 2011-05-30 2011-04-29 63392 Type II enGen JCT20Q3J, J16XQH4J, JIHX7S4J, J41BCY4J Ortho Clinical Diagnostics has received complaints of centrifuge buckets (part number 4412-

R) disconnecting from their supports during centrifugation when using the Hettich Rotanta

46 RSC robotic centrifuges (models 4815, 4816 and 4817), that may be configured with

enGen Laboratory Automation Systems. Centrifuge bucket disconnections may result in

damage to the Hettich centrifuge.

Luminos DRF Siemens AG 2011-05-30 2011-04-06 63437 Type III 10094200 2001 This update instruction provides multiple bug fixes and system improvements, such as,

enhanced direct radiation detection leading to wrong window values, wrong PEX-settings for

spatial frequency parameters leading to black images, imaging system crash with cancel of

reject analysis window, wrong flags in patient list, improvement of auto delete function,

improvement of error 3070/032, and improvement of error 7031/032.

GemStar SP Infusion Suite Database PC Hospira Inc. 2011-05-30 2011-03-24 62617 Type II 13092 72613G1, 84832G1 GemStar devices utilizing the PC application are capable of being programmed for a bolus

lower lockout limit interval less than the programmed hard limit value stored in the GemStar

SP Infusion Suite Database PC application. This could potentially result in the infuser

granting more frequent bolus delivery requests than intended in programming the hard limit

potentially causing over-delivery of medication to the patient.

Skin Prep Wipes Smith & Nephew Inc.

Wound Management Division

2011-05-30 2011-04-12 62939 Type II N/A OG117, OG225, OJ146, OJ147, OK78, OM198 The recalled lots were made in the same facility as other wipe products, including wipes,

swabs and swab sticks, that are the subject of other voluntary recalls due to a potential

bacterial contamination issue.

Waters Mass Spectrometer TQD Waters Corporation 2011-05-30 2011-05-04 63482 Type II N/A QBB1050 There is potential for solvent to leak at the atmospheric pressure ionization (API) source and

ingress into the instrument. There is a remote possibility that the solvent will ignite creating

a potential fire hazard. This issue resulted from a design change. There have been no

reports of solvent ignition in the field. If ignition were to occur, it is unlikely that the fire

would be able to self sustain.

CUSA EXcel + System Integra LifeSciences (Ireland) Limited 2011-05-30 2011-04-15 63100 Type II CUSA EXcel2 HFL1004101IE, HFB1100401IE, HFL1004701IE The CUSA EXcel family of ultrasonic tissue ablators are used in surgical procedures where

fragmentation, emulsification and aspiration of soft and hard tissue is desirable. The EXcel

family of devices is tested against standard 60601 for electrical safety, fire and mechanical

hazard compliance by Underwriters Laboratory (UL) against European standard, UL and

Canadian requirements. However, the three EXcel consoles that have been imported and

distributed in Canada do not have the required specific UL Canada logo.

Stromatolyser-IM Sysmex Reagents America 2011-05-30 2011-04-14 63134 Type II SIM-220A Y0053, Y3354, Y0055 Three lots manufactured between December 2, 2010 and December 6, 2010 that

subsequently tested positive for high background tests.

Syngo RT Therapist Siemens AG 2011-05-30 2011-03-31 63454 Type III 08162815 10003, 10040 Safety advisory notice to inform the users about a potential issue related to patient

treatment with table offsets on Syngo RT Therapist 4.1 and 4.2. as a consequence of this

issue, an incorrect offset may be applied for patient positioning and thus may result in dose

being delivered to the wrong location.

ExactaMix Empty EVA Container Baxa Corporation 2011-05-30 2011-03-08 63483 Type II 737, 738, 739, 740, 741 All lots since 2009/07/23. The retaining ring portion of the manual addition port may become detached upon removal

of the additive port cap. Detachment of the retaining ring can dislodge the septum and the

bag may leak.

OrthoPAT System Haemonetics Corporation 2011-05-30 2011-04-29 63498 Type II 1050-110-ENG, 1050-240-FRN 00001 - 02279-T, 02280-T An OrthoPAT System experienced a blood spill in the centrifuge area. During the cleaning

process, fluid was used to irrigate the centrifuge area. The blood spill drain bag was not

deployed correctly resulting in the drain system to malfunction, and fluid to overflow from

the centrifuge well into the device closure.

Synchron Systems Glucose Reagent Beckman Coulter, Inc. 2011-05-30 2011-04-21 63159 Type II 472500 All lots The current GLUCM (glucose modular) assay is not capable of reporting accurate results

below 10mg/dl on both the LX and DXC systems. There is no discernable trend and the

magnitude of the discrepancy is variable. GLUCM (glucose modular) assay is utilized on

plasma, serum, urine and CSF samples. The current sensitivity claim for the assay is 3

mg/dl for all sample types.

ACTIVE Inhibin A ELISA Beckman Coulter, Inc. 2011-05-30 2011-04-26 63161 Type II 10-28100-1, 10-28100-4 >10 Numbers, Contact Manufacturer A method comparison across all Inhibin A formats and calibrations conducted revealed a

+30% difference in patient dose response for the ELISA Kit when compared to the access.

Prolex Staph Latex Kit Pro-Lab Diagnostics 2011-05-30 2011-04-15 63296 Type III PL80B, PL81B C7992, C7912, C8048, C8117 The Staph Latex Test Reagent in the kit is auto-agghlutinating making the product unusable.

(i.e. agglutionation of the latex particles is occurring without the addition of the test

organism).

A) MAGNETOM Symphony A Tim System Upgrade

B) MAGNETOM Symphony MRI System

C) MAGNETOM Sonata MRI System

Siemens AG 2011-05-30 2011-04-28 63452 Type II A) 10018223

B) 07104594, 07106557

C) 07104719, 07106425

A) 37223, 37227


C) 21118, 21130, 21136, 21158, 21913

Update should help to recognize faulty gradient cable connections and subsequently prevent

those from overheating.

Filterline H Set Infant / Neonatal in N-85 Monitor Kit Covidien LLC 2011-05-30 2011-04-13 63252 Type II N-85 >10 Numbers, Contact Manufacturer Oridion Medical,the manufacturer of Filterline products has discovered an issue with

specific lots of the Filterline H Set Infant / Neonatal (part 006324) distributed with

Nellcor(Covidien) N85 monitor kits. The issue concerns the presence of fine plastic strands

inside the endo-tracheal tube side of the airway adapter which may become dislodged and

inhaled by the patient.

A) Adapta Dual Chamber Rate Responsive Pacemaker

B) Versa Dual Chamber Rate Responsive Pacemaker

C) Sensia Dual Chamber Rate Responsive Pacemaker

D) Relia Dual Chamber Pacemaker

E) Relia Dual Chamber Rate Responsive Pacemaker

F) Kappa 700 KDR Dual Chamber Pacemaker

G) Kappa 700 KD Dual Chamber Pacemaker

H) Dual Chamber Rate Responsive Pacemaker

I) Dual Chamber Atrial / Ventricular Sensing Pacemeker

J) Enpulse Dual Chamber Rate Resposive Pacemaker

K) Enpulse Dual Chamber Pacemaker

L) Enpulse Dual Chamber Atrial / Ventricular Sensing

Pacemaker

Medtronic Inc. 2011-05-30 2011-04-04 63274 Type II A) ADD01, ADDR01, ADDR03, ADDR06, ADDRL1, ADDRS1, ADVDD01

B) VEDR01

C) SED01, SEDR01, SEDRL1

D) REVDD01

E) REDR01

F) KD703, KDR706

G) KD703, PHM621259S

H) KDR803, KDR903, KDR906, KDR931, KDR933

I) KVDD901

J) E2DR01, E2DR03, E2DR06, E2DR21, E2DR31, E2DR33

K) E2D03

L) E2VDD01













The purpose of this action is to inform physicians who have implanted or follow patients

implanted with dual chamber pacemakers about a rare, approximately 1 in 18,000 devices,

measurement lock-up condition that may inappropriately trigger ERI / RRT in specific

Medtronic dual chamber pacemakers. In rare instances, these devices exhibit a condition in

which the hardware component of the measurement system may lock up, resulting in the

device declaring ERI (elective replacement indicator) / RRT (recommended replacement

time). This device then inappropriately defaults to an ERI state. When devices exhibit this

condition, they do not actually have a depleted battery, but rather the device displays ERI

due to the erroneous voltage measurement. When the false ERI occurs, the device is

reverted to a defined set of parameters (VVI mode at 65 beats per minute). A device

exhibiting this condition can be resolved through the use of a specially configured

programmer and software reset application to clear the ERI / RRT condition. The IPG is not

modified, but simply returned to its previous settings. It should be noted that this issue does

not shorten the actual device longevity after a reset.

COBAS AmpliPrep / COBAS TaqMan HCV Test Roche Molecular Systems, Inc. 2011-05-30 2011-04-14 62989 Type II N/A All lots Under-quantitation of a subset of genotype 4 patient specimens (by approximately 1.0 to 1.5

log10) in the absence of any sequence mismatches.

A) Liason Analyzer Class III

B) Liason Analyzer Class 2

Diasorin Inc. 2011-05-30 2011-04-27 63449 Type II A) 15970

B) 15970

A) All lots

B) All lots

During the manufacture of Liasion Analyzers two dilutor syringes malfunctioned. The glass

body of the syringe became detached from the metal collar. The defect does not affect all

dilutor syringes and all reported failures in the field have occurred within a week after

installation, during routine use.

Aquilion 64 System Toshiba Medical Systems Corporation 2011-05-30 2011-04-26 63539 Type II TSX-101A/E, TSX-101A/EX, TSX-101A/H,

TSX-101A/HX

ECA0552037, ECA05Z2249, HCA0642155,

HCA06Y2410,

HCA06Z2467, HCA0782875, HCA07X2919,

HCA07Y3000,

HDA0632105

In systems with the ECG modulation function, which permits the tube current to be adjusted

in synchronization with the ECG waveform, it has been found that in CT examinations using

this function, X-ray output may not be varied as specified. As a result, an error may occur

and scanning may be interrupted.

A) Varian Clinac Linear Accelerator

B) Trilogy Radiotherapy Delivery System

C) Clinac IX Radio Therapy Delivery System

D) Novalis TX Linear Accelerator

Varian Medical Systems, Inc. 2011-05-30 2011-02-24 63660 Type II A) 2100C, 21EX, 21EXD, 21EXDS, 21EXS, 23EX, 600C, 600N, 6EX

B) Trilogy

C) Clinac IX, Clinac IXS

D) Novalis TX


B) H294934, H294403, H294750, H293883,

H291172, H140836, H294134, H293787,

H294551, H291166


D) H294674

An anomaly has been identified for type 3 hard wedges whereby the labelling on the wedge

tray may not correctly match the wedge body. For example, a 45 degree wedge body

mounted on a tray labelled "60 degrees" or a 15 degree wedge body mounted on a tray

labelled "30 degrees". In all cases the wedge body is labelled with the correct wedge angle.

Correct VPS Light Extra Body Kerr Corporation,

Also trading as Pentron Clinical

2011-05-30 2011-05-11 63677 Type III N/A 174207, 174758 A complaint that product set faster than specified on directions for use was confirmed in

retained samples and returned product.

Build-it FR model # A3 Pentron Clinical Technologies, LLC 2011-05-30 2011-05-09 63679 Type III N32AE 3564518 One complaint indicating syringes for A3 shade of Build-it FR were packaged in outer boxes

as A2. The syringes contain the correct shade of A3.

A) Renasys G Gauze Dressing Kit - Complete Wound

Drainage Kit

B) Renasys G Gauze Dressing Kit with Round Drain

C) Renasys G Gauze Dressing Kit with Flat Drain

D) Renasys G Gauze Dressing Kit with Channel Drain

E) Renasys G Gauze Dressing Kit with Port

Smith & Nephew Inc.

Wound Management Division

2011-05-30 2011-04-18 63258 Type II A) N/A

B) N/A

C) N/A

D) N/A

E) N/A

A) 26310F, 29910D

B) 09710K, 09510T, 24210N, 28410J, 16610E,

18610G, 21010E, 27810D

C) 10310N, 11410E, 00811N, 09510N, 30310H,

35510H

D) 00811K, 09510U, 27210D, 27710W, 28410H,

29210F, 29210P

E) 2011010746, 2010122387, 2011010747

It has been determined that the wipes in the kits subject to this correction were made in the

same facility as other wipe products, including wipes, swabs and swab sticks, that are the

subject of other voluntary recalls due to a potential bacterial contamination issue.

A) Cobas Integra Lipase Colorimetric

B) Lipase Colormetric for Cobas

Roche Diagnostics GMBH 2011-05-30 2011-05-02 63295 Type III A) N/A

B) N/A

A) All lots

B) All lots

Reduction of the I-index claim on the Cobas C Systems from 60mg/dl to 50mg/dl following

the increase of concentration of a non-reactive stabilizer in the Lipase R2.

BacT/Alert - FA Reagent Bottle Biomerieux, Inc. 2011-05-30 2011-04-15 62902 Type II 259791 1027481 Internal investigations have shown that the charcoal suspension density in the FA reagent

bottle does not meet specifications.

A) EOS System

B) sterEOS Workstation

EOS Imaging 2011-05-30 2011-04-13 62903 Type II A) EOS

B) sterEOS Workstation



EOS Imaging has discovered that "print true size" print requests from the EOS Acquisition

station or the sterEOS Image station may be affected by a different enlargement factor

during printing. Therefore, measurements taken manually could be incorrect if the

dimensions are not converted according to the scale used on the printed image.

Refa8 TMS International BV 2011-05-30 2011-04-04 63158 Type II 0108YYNNNN 108070011 The use of a defective Refa8 amplifier in combination with an accessory that would also be

defective may pose a safety hazard that is only present in the case of invasive

measurements.

Uri-Drain Male External Catheter with Skin Prep -

Large

Covidien LLC 2011-05-30 2011-04-29 63330 Type II 8884732598 020272164, 100370664 Covidien is conducting a recall regarding specific lots of Uri-Drain Male External Catheter

which include a Smith and Nephew Brand Skin-Prep Protective Wipe. The impacted skin

protective wipes may be contaminated with bacteria.

Duo-Decapolar Electrophysiology Catheter Biosense Webster Inc. 2011-05-30 2011-05-10 63712 Type III D728260RT 15282044M Biosense Webster Inc. recently became aware that the Duo-Decapolar Electrophysiology

Catheter shipped to customers did not contain the correct instructions for use (IFU). This

issue only affects the IFU for the device and not the catheter itself.

A) Paradym DR ICD

B) Paradym VR ICD

Sorin CRM S.R.L. 2011-05-30 2011-05-06 63721 Type III A) 8550

B) 8250



It was discovered that the bills of materials for the packaging of the Paradym DR and VR

ICD models manufactured by Sorin CRM S.R.L. for Canada included a reference to an

incorrect patient booklet, the ICD/CRT patient booklet ref O263, instead of the correct

booklet, the ICD patient booklet ref N582.

A) STAT 2 Pumpette Primary Set

B) STAT 2 Pumpette Extension Set

Conmed Corporation 2011-05-30 2011-04-26 63108 Type II A) P-S2V-60, P-S2V-60 N

B) P-S2-12, P-S2-12 N

A) 0603241-0811031, 0603241-1006094

B) 0603241-1101064, 0603241-1103114

Complaints have been received of some devices exhibiting inaccurate flow rates and

leakage. If the device is unable to regulate flow as set and confirmed by the attending

medical staff and the delivery of essential medications or treatment is dependent on the

device's function, this may result in possible injury to the patient.

NucliSENS EasyQ Enterovirus Biomerieux BV 2011-05-30 2011-05-04 63389 Type III 200288 09102001 Analytical studies showed that the NucliSENS EasyQ Enterovirus Kit can not detect

enterovirus serotype 68 and rhinovirus serotype 87. Therefore, Biomerieux revised the

instruction for use of NucliSENS EasyQ Enterovirus products in order to remove these

serotypes from the list of the serotypes detected by the kit.

NovaFlex Delivery System Edwards Lifesciences LLC 2011-05-30 2011-05-04 63778 Type I 9350FS23, 9350FS26 >10 Numbers, Contact Manufacturer An inability to articulate the NovaFlex Delivery System may lead to procedural

complications including vessel perforation and potentially patient death. Due to a change in

manufacturing processes instituted at Edwards in August 2010, there are reasonable

grounds that all NovaFlex units manufactured after this date will function as intended.

Although it is believed the likelihood that other units have been impacted is very low,

Edwards is recalling all NovaFlex Delivery Systems manufactured before August 2010 in

order to eliminate this risk.

Solution packs to ABL80 Basic/Flex


2011-05-16.

Radiometer Medical APS 2011-05-30 2011-04-18 63213 Type III 944-174, 944-309* 62718, 62784, 62871, 63038, 63134, 63390,

63480, 63620, 63718,

63864, 62785*

Affected lots of Solution packs were produced with a wrong conductivity value encoded into

the chip. This causes a minor negative bias for the HCT (hematocrite) measurement of 1 to

2% and following failure of the air detection system.

A) TotalCare Bariatric Bed

B) TotalCare P1900 with Scale

Hill-Rom, Inc. 2011-06-13 2011-01-26 59538 Type II A) N/A

B) P1900

A) J079AM6657 to J163AM8107

B) J079AM6657 to J163AM8107

A patient who was on a TotalCare bed was medicated for a weight of 53kg when in fact the

actual weight of the patient was 73kg. The patient expired the next day and it is inconclusive

as to whether the scale was the contributing factor.

Custom Sterile Breast Packs Cardinal Health 2011-06-13 2011-04-12 63022 Type II SBA30MAVWA 954658, 966888, 971890, 990054 Cardinal Custom Packs contain the Ethicon Blake silicone drain, connector or J-vac

reservoir which are under recall due to the potential for the sterile barrier of the product

packaging to be compromised.

Gambro Accessory S-660-C

(Hemodialysis Y Connector)

Gambro Dasco S.P.A. 2011-06-13 2011-04-26 63171 Type II 101354-6431233 1035, 1036, 1037 Gambro has become aware of a possible defect on three lots of the Gambro Accessory S-

660-C. The defect is a small hole at the level of the female luer connector that could

potentially result in an intake of air into the bloodline. The air could subsequently reach the

patient without passing through the "air blood" protective system of the dialysis machine.

The small hole is not visible to the naked eye.

Advia Centaur HIV 1/O/2 Enhanced (EHIV) Assay Siemens Healthcare Diagnostics Inc. 2011-06-13 2011-04-29 63251 Type III 01463908 >10 Numbers, Contact Manufacturer Two U.S. distributed lots of the Advia Centaur, Centaur XP, and Centaur CP EHIV reagents

are exhibiting instability. This instability results in the positive control 3 (type O low control)

recovering low and out of specification. Reagent lots distributed outside the U.S. have not

demonstrated this instability, however as a precautionary measure, the shelf life is being

reduced.

Sigma Spectrum Infusion Pumps Sigma International, General Medical Apparatus 2011-06-13 2011-04-07 63259 Type I 35700 >10 Numbers, Contact Manufacturer There is a potential for certain units to fail causing a potential back-flow, and/or free flow

condition which could result in over-infusion during use.

A) BV Pulsera Mobile C-Arm System-9 inch. and 12 inch

versions

B) BV Endura Mobile C-Arm System

Philips Medical Systems Nederland B.V. 2011-06-13 2011-04-29 63279 Type II A) 718095

B) 718074

A) N/A

B) N/A

The fixing strap of the laser aiming devices may inadvertently be detached and land on a

patient.

A) Resolution Clip

B) Pinnacle Pelvic Floor Repair Kit

C) Advantage Mid-Urethral Sling System

D) Advantage Fit System

E) Accumax 365 Single-Use Holmium Laser

Boston Scientific Corporation 2011-06-13 2011-05-03 63444 Type II A) M00522610, M00522611, M00522612

B) M0068317050

C) M0068502000, M006850200051

D) M0068502111

E) M0068404020

A) ML000019C2

B) ML00000034

C) M0068502000, M006850200051

D) M0068502111

E) M0068404020

The devices were stolen while en route to sterilization facility sometime between April 8,

2011 and April 11, 2011.

Blood Parameter Monitoring System 101 Terumo Cardiovascular Systems Corporation 2011-06-13 2011-05-09 63652 Type II 101 1000 to 5556 Potential for electromagnetic interference (EMI) to affect the accuracy of the values

displayed by the CDI 101 system .

A) SERVO-s Ventilator System

B) SERVO-i Ventilator System

Maquet Critical Care AB 2011-06-13 2011-05-12 63674 Type II A) 6640440

B) 6487800



There have been 4 reported instances (not in Canada) where SERVO-i ventilators have

malfunctioned when being used during high dose radio therapy by Linear Accelerator

(Linac). They stopped working, generated different error codes, reset and started again. No

permanent damage or harm to the patient occurred. We are informing our customers that

SERVO-i and SERVO-s ventilators are not to be used during high dose radiotherapy by

Linear Accelerator (Linac). The manufacturer has never claimed that these devices could be

used in this type of environment.

IdentiCult Albicans Test Kit Biomerieux, Inc. Portland 2011-06-13 2011-05-09 63731 Type II 302338 513391-1, 516815-1, 518661-1, 520320-1,

522999-1, 524231-1, 525260-1

Some lots of IdentiCult Albicans Test Kits were incorrectly shipped. Shipping requirements

for this product include ice packs to be added to the shipping carton. Affected lot numbers

were shipped incorrectly without ice packs which could potentially lead to incorrect results if

the product has degraded during shipping.

VITROS Chemistry Products VALP Reagent Ortho-Clinical Diagnostics Inc. 2011-06-13 2011-05-12 63799 Type III 6801710 1511-14-1230, 1511-14-9776, 1511-14-9894,

1511-14-1094,

1511-14-9637

Ortho Clinical Diagnostics (OCD) was notified by a proficiency testing agency that results

using VITROS Chemistry Products VALP Reagent were negatively biassed compared to

other manufacturers. OCD performed an internal investigation and confirmed that patient

results are also affected by this issue. As a result, OCD will be adjusting the calibrator

values for VITROS VALP Reagent.

RealSeal .04 Taper Points Ormco Corporation,

Also trading as Sybronendo

2011-06-13 2011-05-11 63846 Type III 972-2420 126908 Two complaints regarding labelling of RealSeal .04 Taper Point #20 with additional label M-

L. Actual contents are not RealSeal .04 Taper Points.

Correct Plus Putty Kerr Corporation,

Also trading as Pentron Clinical

2011-06-13 2011-05-13 63856 Type III Q34H 179966, 198019 Correct Plus Putty, dental impression material, does not set within the established

specifications.

Short Adhesive Removing Replacement Carbide Tip Ormco Corporation

Also trading as Sybron Implant Solutions

2011-06-13 2011-05-13 63866 Type III 803-0675, A 09J9J Short Adhesive Removing Replacement Carbide Tips, part # 803-0675 (Lot 09J9J) were

mispackaged. Instead they contain Long Adhesive Removing Replacement Carbide Tip,

part # 803-0975.

Bond-1 SF Pentron Clinical Technologies, LLC 2011-06-13 2011-05-12 63868 Type III N03M 3598581 Sealed bags of Bond-1 SF 50-pack were shipped without box packaging and kit components.

BD BBL Oxacillin Screen AGAR Becton Dickinson and Company 2011-06-13 2011-04-21 63246 Type II 221952 1034119 Customer reports were received for breakthrough growth of quality control organisms

staphylococcus aureus ATCC 29213 and false positive patient samples.

A) Advanced Perfusion System 1 Base Unit

B) Advanced Perfusion System 1 Roller Pump

Termo Cardiovascular Systems Corp. 2011-06-13 2011-04-29 63278 Type II A) 801763

B) 801041, 816571

A) 0011-1438

B) 4080-6689, >10 Numbers, Contact

Manufacturer

Large roller pump tube clamp mechanism may fail to function, making it difficult to remove

or insert the tubing.

GENius Multi-Channel RF Ablation Generator Medtronic Ablation Frontiers LLC 2011-06-13 2011-05-05 63535 Type II 990018 2010004165, 2011003251, 2010004164,

2010145144,

2010145134, 2010004105, 2010004137,

2010145145, 2010145147, 2011003252

The version 11 software is unable to detect a catheter fault that occurs due to either an

intermittent resistive connection or a thermocouple short proximal to an electrode. When

this fault is not effectively detected, the displayed temperature will be lower than the actual

tissue temperature. If the actual tissue temperature becomes excessive it may result in

coagulum and/or char formation during an ablation procedure. Formation of coagulum/char

is considered a hazardous situation which could lead to patient harm (thrombo-embolic

complications).

Symphony Automated Staining System Ventana Medical Systems Inc. 2011-06-13 2011-02-11 63847 Type III N/A 390051-390060 The implementation error of the change order for new software in production, 10 Symphony

instruments serial number 390051-390060 were manufactured and distributed with software

V1.3.2 installed with a V1.3.1 dual air safety valve configuration rather than the V1.3.2

single air safety valve configuration.

PAS-210 Remote Active Speakers Kit Philips Medical Systems 2011-06-13 2011-05-04 63448 Type II M3150A, M3151A, M3151B, M3150, M3154 N/A Reports received of intermittent loss of audio at Intellivue Information Centers, where

Philips-supplied PAS-210 Remote Active Speakers Kit were in use. There are two problems

that can lead OT intermittent loss. 1) Using a non-Philips supplied audio cable with the PAS-

210 Remote Active Speaker Kit can prevent proper positioning of the cable and cable

retention bracket. 2) When the audio cable supplied with the PAS-210 Remote Active

Speaker Kit is used, possible intermittent cable connection can occur causing loss of audio.

Air Bubble Detector Module and Occluder Terumo Cardiovascular Systems Corp. 2011-06-13 2011-03-11 63248 Type II 802110, 803480 01417, 01653, 01721, 01724, 00706, 00874, Malfunction reported of the Air Bubble Detector (ABD) System or the OM. A faulty

component on the module's application board was found which can cause the ABD System

or Occluder to fail.

Acticon Artifical Bowel Sphincter Control Pump American Medical Systems Inc. 2011-06-13 2011-05-13 63785 Type II 72402287 35821004 - 690865010 With the introduction of a replacement mold inconsistency was noted between molds. The

previous mold was not producing parts in accordance with the released component drawing

and use of new valve block mold resulted in a lower average activation pressure.

A) Sphincter 800 - Control Pump

B) AMS 800 Urinary Prosthesis Control Pump

American Medical Systems Inc. 2011-06-13 2011-05-10 63938 Type II A) 72400098

B) 72404127

A) 331544001-708953020

B) 517943001-707608020

With the introduction of a replacement mold inconsistency was noted between molds. The

previous mold was not producing parts in accordance with the released component drawing

and use of new valve block mold resulted in a lower average activation pressure.

HEMOCHRON Jr. Prothrombin Time Cuvettes International Technidyne Corp. 2011-06-13 2011-05-10 63904 Type II J201 M0JPT095, A1JPT002, A1JPT017, H0JPT078 International Technidyne Corporation has determined that certain lots of HEMOCHRON Jr.

Prothrombin Time Cuvettes demonstrate a higher bias than historically observed when

compared to laboratory reference instruments. While the lots in question were within

specification and met quality control release criteria, a shift in bias occurred that was

coincident with a change in a lot of raw material used in the reagent formulation.

Cement-It Dental Cement Pentron Clinical Technologies, LLC 2011-06-13 2011-05-09 63843 Type III N33, N33A 186665, 186676 One complaint that Cement-It Dental Cement set faster than listed in directions for use and

in release specifications.

A) 1500T14 Cardiac Ablation System-Generator

B) 1500T14 Cardiac Ablation System-Remote Control

Irvine Biomedical, Inc.

A St. Jude Medical Company

2011-06-13 2011-05-09 63649 Type II A) IBI-89017 (89017) (1500T1)

B) IBI-89018 (89018)

A) N/A

B) N/A

St. Jude Medical (SJM) has identified the potential for the failure of the generator and

remote control to properly respond to key presses resulting in unexpected energy delivery or

the inability to discontinue energy delivery with the start/stop button. The buttons on the

console and/or remote may malfunction when the indiff connector or the remote control

connector on the console of an impacted generator receives an electrostatic discharge

(ESD).

Cholestech LDX Analyzer Biosite Incorporated 2011-06-13 2010-10-06 60941 Type II 10-983 SC0146 A reassignment of the ranges for HDL cholesterol in the materials is necessary.

Leica Peloris Rapid Tissue Processor Leica Biosystems Melbourne Pty Ltd. 2011-06-13 2011-04-10 63137 Type II 26.0005 0265062B The Peloris II Tissue Processor potentially has a faulty impellor. This potential non-

conformance has the capability to lead to reagent carry-over from one processing step to

another. The non-conforming impellors have a faulty seal, which could result in reagent

seeping into and out of the impellor cavity during tissue processing. The total volume of

reagent that could seep uncontrollably in and out of the impellor cavity is less than 1ml.

Lite Wand II (Halogen) Thompson Surgical Instruments, Inc. 2011-06-13 2011-05-03 63453 Type II 400012 N/A These Lite Wands were originally classified as class I, however upon further discussion, it

was determined that this device could be exposed to fat and blood and is therefore

considered invasive and should therefore be class II, per rule 1(1) subject to subrules (2)

and (3), all surgically invasive devices are classified as class II.

Access Ostase Calibrators and Access Ostase QC Beckman Coulter, Inc. 2011-06-13 2011-05-09 63804 Type II 37305 >10 Numbers, Contact Manufacturer Ostase Calibrator and QC vials have been observed to have an increased rate of breakage

when stored at -70ºC and thawed prior to kitting and shipment to the customer. The cracked

calibrator and QC vials break and leak reagent in the kit box during shipment to customers.

Access Immunoassay System - PAPP-A

(Pregnancy Associated Plasma Protein) Assay

Beckman Coulter, Inc. 2011-06-13 2011-05-09 63808 Type II A48571 013968, 014411, 015795, 017948, 830320,

914085, 919454

Beckman Coulter Inc. identified the following issue with the above listed product: 1.Access

PAPP-A may exhibit increased imprecision for samples tested from the first two replicates

of a reagent pack as compared to the remaining replicates. 2. This issue is only observed

on the Access platform, including Access 2, Synchron LXI 725, and UniCel DxC 600i. 3.

UniCel DxI platforms are not impacted, including UniCel DxI 600, UniCel DxI 800, UniCel

DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC 660i.

UniCel DxH 800 Coulter Cellular Analysis System Beckman Coulter, Inc. 2011-06-13 2011-05-09 63812 Type II 629029 All lots The probe wash collar tubing of the sample aspiration module (SAM) may become stretched

or trapped during routine use of single-tube presentation station. When the tension on the

tubing is severe, the tubing may not be able to return to its home state and may pull the

wash collar out of alignment with respect to the aspirate probe. The misalignment may

result in incorrect seating of the probe wash collar and incomplete fluid collection during

cleaning. Excess fluid may be dripped across internal surfaces.

Normlgel (15 Gram) Molnlycke Health Care AB 2011-06-13 2011-05-16 63909 Type III 371500 10I29-156-41665 The product identifier on the retail box packaging (371580) is the wrong number and does

not match the (correct) product identifier on the individual case packaging (371500).

A) Coulter LH 780 Hematology Analyzer


C) Coulter LH 500 Hematology Analyzer


B) 6605632

C) 178833

A) All lots

B) All lots

C) All lots

Beckman Coulter Inc. identified the following issues with the above listed products: issue 1:

After downloading interlaboratory quality assurance program (IQAP) files to removable

media, the system prevents access to system setup screen and history logs. Issue 2: The on-

line help (IFU) instructions for LH 750 and LH 780 instruments do not provide the correct

procedures to format a disk (CD) for saving or archiving data where those instruments are

connected to small form factor (SFF) computers.

Capsule Neuron UMPC Capsule Technologie 2011-06-13 2011-03-23 63995 Type II DC-NU-UMPC N/A Capsule Neuron UMPC experiences three failure modes that may prevent the parent device

from operating according to specifications: (1) Data cached due to server unavailability is

not delivered to the server after server availability is restored. (2) Compact flash failure may

cause the file system to be corrupted resulting in system hangs, lock-ups or crashes. (3)

Batteries can discharge completely even though the device is connected to power.

Ventilateur Legendair - Unite Principale Airox S.A. 2011-06-13 2011-05-17 63996 Type I 4095700, 4095705, 4095905 >100 Numbers, Contact Manufacturer - Covidien Covidien informs of a potential failure of audible backup alarms in the event of power loss to

the Ventilator Legendair.

A) 1.0T Signa Horizon Magnetic Resonance

B) 1.5 Signa Horizon Magnetic Resonance

C) 1.5T Signa Horizon LX Magnetic Resonance

D) Signa 1.5T Excite HD - Magnet

E) 3.0T Signa HDX MR Sysem - Main Unit

F) 1.5T Signa HDX MR System - Main Unit

G) Discovery MR750 MR System - Magnet

H) 1.5T Signa Infinity Twinspeed with Excite

I) Signa 3T MR System - Parts for Main Unit

J) Signa Excite 3.0T G3 Magnet

K) Signa 1.5T MR System - Main Unit

L) Discovery MR450 1.5T MR System - Main Unit

M) Signa HDT 1.5T MRI System - 16 Channel

GE Medical Systems LLC 2011-06-13 2010-11-10 57849 Type II A) M1800MA

B) M1000MA

C) M1000RA/RD/RF/RG

D) M1060LG

E) M3335JK

F) M3335J, M3335JA, M3335JG

G) M7000MA, M7000MC

H) M3000TD

I) M1060YW

J) M3333TD

K) SIGNA HDXT 1.5T MR SYSTEM

L) DISCOVERY MR450 1.5T MR S

M) S7504HP



C) All Serial Numbers

D) All Serial Numbers

E) All Serial Numbers

F) All Serial Numbers

G) All Serial Numbers

H) All Serial Numbers

I) All Serial Numbers

J) All Serial Numbers

K) All Serial Numbers

L) All Serial Numbers

M) All Serial Numbers

If gradient cables are inadvertently swapped while servicing and geometry check not

performed as required in procedure, images may be flipped left-right with incorrect

orientation annotation.

Immulite 2500 CMV IGG Siemens Healthcare Diagnostics Products Limited 2011-06-13 2011-04-28 63220 Type II REF L5KCVG2 SMN 13081220 The Immulite 2500 CMV IGG assay does not have Health Canada licensing approval.

Pinnacle Pelvic Floor Repair Kit Boston Scientific Corporation 2011-06-13 2011-05-11 63913 Type II M0068317050 1ML0070801 A portion of units may exhibit low tensile strength between the needle and the suture, which

could potentially lead to needle detachment during mesh leg replacement. If needle

detaches during placement, user may elect to leave the needle in body or try to locate

needle and attempt to retrieve it.

A) Brilliance 40/64 Slice CT System

B) Brilliance CT Big Bore System-Main Unit

C) Brilliance 64 Slice CT System-Main Unit

D) Brilliance ICT System-System

E) Brilliance 6/10/16 Slice CT System

F) Brilliance CT System (16P)

Philips Medical Systems (Cleveland), Inc. 2011-06-13 2011-05-20 63918 Type II A) 4550 11004011

B) 4535 670 88051

C) 4550 110 00921

D) 728306

E) 4535 670 73181, 4535 670 78851

F) 453567005721

A) N/A

B) N/A

C) N/A

D) N/A

E) N/A

F) N/A

Philips received a complaint that the patient table collapsed in the vertical direction with a

patient on the table. Philips has determined that the root cause was a failure with the

vertical brake hub of the patient support.

Spacelabs Medical Capnography Module Spacelabs Medical, Inc. 2011-06-13 2011-05-16 63922 Type II 91517 >100 Numbers, Contact Manufacturer Spacelabs Healthcare discovered during internal testing that the capnography module

resets 20 seconds after power failure, instead of after 3 minutes as specified. This reset

clears the ram and the module returns to default settings.

A) Hitachi Creatinine Kinase-MB Liquid (CK-MB)

B) Hitachi Creatine Kinase Liquid, Acc. to IFCC (CK)

C) CK (Creatine Kinase) for Cobas C701 Analyzer

Roche Diagnostics GMBH 2011-06-13 2011-05-13 63928 Type III A) 12132834216, 12132893216

B) 04580591190, 04580613190, 12132524216, 12132672216

C) 05168546190

A) All lots

B) All lots

C) All lots

The manufacturer implemented a new master application for the reagents that would require

a change in the measuring range of the methodologies as documented in the respective

package insert and instrument configuration parameters.

PleuraFlow Catheter System Clear Catheter Systems 2011-06-13 2011-04-19 63930 Type III PF-20, PF-32 7844-05, 7844-06 Removal of product from distribution that exhibits possible vacuum/suction leaks. The leak

is attributed to incomplete bond between the chest barb connection and the guide tube.

External Nasal Splint Kit Invotec International Inc. 2011-06-13 2011-05-20 63933 Type II 20-10101 29810 The Nasal Splint Kit contains a "skin-prep protective wipe". This wipe is subject to a recall

by the manufacturer "The Triad Group/H&P Industries" due to potential bacterial

contamination with Bacillus cereus.

Advantage Workstation Thoracic VCAR GE Medical Systems SCS 2011-06-13 2011-05-06 63538 Type II 5339892-X N/A When using the summary table feature on Thoracic VCAR to display data, incorrect patient

name will be displayed if the user does not exit the application in between the analysis of

two consecutive patients. If the user did not exit the application, the correct imaging study

will appear and the data on the summary table will contain the results of the current patient

imaging study, however, the previous patient name will be displayed on the summary table.

This summary result may be separated from the remainder of the CT imaging exam if it is

printed on film or paper and incorrectly inserted in another patient's file. This issue may

cause confusion and possible incorrect assessment. No adverse event has been reported

related to this issue.

OneTouch Delica Lancing Device LifeScan Europe, A Division of Cilag G.m.b.H. International 2011-06-13 2011-05-23 64104 Type II 012-839 A-58277 Individuals attempting to remove a lancet from the OneTouch Delica Lancing Device

without following the instructions for use may experience an accidental needle stick. In

addition, over tightening of the cap may cause the needle to be exposed after firing, which

could also result in an accidental needle stick.


B) Synchron LXI 725

C) Synchron LX20 PRO


B) 476501

C) 476100

A) All lots

B) All lots

C) All lots

Beckman Coulter Inc. has confirmed the following maintenance-related hardware issues can

cause or contribute to erroneous electrolyte results on the Synchron LXR20, Synchron

LXR20 PRO and Synchron LXRI 725 clinical systems: 1. Ratio pump wear, 2. Silver iodide

build-up on the chloride electrode, which if not removed may affect chloride performance

and shorten the usable life of the electrode, and 3. Microbial contamination introduced into

the system via the deionized water source, reagent straws, or other external sources. The

use of incompatible bleach and saline products for the twice-weekly flow cell cleaning

procedure may introduce electrolyte instability in the Synchron LX20 system.

Sample Tape Kit Medtronic MiniMed 2011-06-27 2011-04-08 62956 Type II MMT-643 N/A IV Prep Antiseptic Wipes are packaged inside the "Site Adhesive Sample Kit". These wipes

are part of a recall by the distributor "Smith & Nephew" due to a potential bacterial

contamination found at the manufacturer "The Triad Group". (Lot# for "IV Prep Antiseptic

Wipes": 9K141, 9K142, 9K143, 0F131, 0F140, 0G249, 0G255, 0G256, 0G259, 0K139,

0K140, 0K193, 0M180, 0M216, 1A212, 1A213).

Centricity Laboratory-Core Lab GE Healthcare 2011-06-27 2011-05-04 63451 Type II CORE N/A Centricity Laboratry instrument interface to data innovations (DI) is processing a preliminary

result instead of the final result from the process manager (PSM). When PSM reruns

(repeats) a test, the PSM sends both preliminary and final results in the same result

message, but only the preliminary result is filed and reported.

Colleague Volumetric Infusion Pump Baxter Healthcare Corporation 2011-06-27 2011-05-06 64128 Type II 2M8161 15084164CC, 15102333CC During a review of records at the Buffalo Grove Global Technical Services Center in the

U.S., it was determined that a service technician may have failed to perform the dielectric

voltage withstand (HIPOT) test on Colleague Infusion Pumps that were serviced between

April 1, 2008 and November 14, 2008.

A) MPS Myocardial Protection System Console

B) MPS2 Console

Quest Medical, Inc. 2011-06-27 2010-08-01 64204 Type III A) 5001000

B) 5201260



User update, a voluntary safety alert to preventatively address inadequate cooling reports

and educate customers on the possibility of damage to the MPS or MPS2 Console under

these use conditions.

A) Bucky Diagnost

B) Trauma Diagnost

Philips Medical Systems DMC GMBH 2011-06-27 2011-05-20 64032 Type II A) 9890 010 83821

B) N/A

A) N/A

B) N/A

In the manual exposure mode, if the exposure switch is pressed at the same time as one of

the technique buttons, it is possible that one of the technique parameters (KV, MA, MAS)

may continue to ramp up or down, resulting in a higher or lower x-ray dose than intended.

An additional exposure may be needed in order to obtain an image of desired quality.

CADD-Solis Infusion Pump, Model 2120 Smiths Medical ASD, Inc. 2011-06-27 2011-05-24 64115 Type I 21-2120-0100-50 Serial Numbers 1014628 and lower Smiths Medical has become aware of a small number of complaints for significant under-

delivery/non-delivery of fluids when the CADD medication cassette reservoir or

administration set is not correctly latched to the pump.

Eon Mini Neurostimulation System-Implantable Pulse

Generator

Advanced Neuromodulation Systems, Inc. 2011-06-27 2011-05-25 64172 Type II 3788 702822, 704723, 710755, 711005 Device has lost the ability to communicate or recharge, resulting in loss of pain relief and

possible subsequent explant. In the cases reported, the duration between recharges became

progressively shorter until the IPG failed to charge or there was a sudden loss of power

which resulted in device replacement.

A) Ysio Radiography X-ray System Full Motorized

B) Ysio Radiography X-ray System Semi Motorized


B) 10281163


B) 30010, 30064, 30068, 30069, 31039, 31083

When the function "lower table height" is activated by the user and a patient is sitting next to

the table and patient's lower extremities are under the table top, the possibility exists that

parts of the table may impact the patient's lower extremities.

Remington Medical 600-D Drainage Bag


Remington Medical, Inc. 2011-06-27 2011-01-18 61102 Type III 600-D 083302, 100283, 101792 Recall initiated due to a potential of these draining bags to leak during patient use.

Important notice: on May 17, 2011 the recall have been expanded to lots # 100283 and

# 101792.

Aquilion One System - Main Unit Toshiba Medical Systems Corporation 2011-06-27 2011-05-27 64173 Type II TSX-301A/2 >10 Numbers, Contact Manufacturer In Aquilion One System the following software issues have been noted. (1) The confirmation

may not be displayed properly during scanoscopy. (2) If the PGP hard split option is used

and the scano skip button is pressed, the second scanoscopy may not be completed. (3)

The use of PGP hard split may result in an error in image display processing. (4) If more

than 10 characters is entered in the image comment, the system software will terminate

abnormally.

A) Cement-It - Cementation System Kit

B) Cement-It-Automix Syringes, Catalyst & Base

Pentron Clinical Technologies, LLC 2011-06-27 2011-05-20 64219 Type III A) N33

B) N33A

A) 186665

B) 186676

The product hardens faster then what was specified in the instructions.

GEM Premier 3500 System Instrumentation Laboratory Company 2011-06-27 2011-04-01 64262 Type II 00026000000 >10 Numbers, Contact Manufacturer The GEM Premier 3500 System has identified that the patient ID from the previous sample

was transmitted to the wrong file on their GEM Premier 3500 instrument. This event occurs

specifically when they misuse the GEM Premier 3500 barcode gun by repeatedly clicking

the gun, which can potentially cause the instrument under certain conditions, to attach the

test results to an incorrect patient ID.

Anti-HAV Kit Roche Diagnostics GMBH 2011-06-27 2011-05-27 64018 Type III 04854977190 16065601 The reagent Elecsys anti-HAV revealed a signal increase for calibrators/controls and sample

patients when the reagent was left onboard the analyzer for more than 3 weeks.

A) Elekta Precise Treatment System

B) Elekta Synergy Platform

C) Elekta Infinity

Elekta Limited 2011-06-27 2011-05-06 64096 Type II A) MRT 6001, MRT 6011

B) XRT 0401, XRT 0411

C) XRT 1501, XRT 1511

A) 105627, 105785, 151311, 105821, 105871,

105706, 151578


C) 152094, 151939, 151940, 151941

A malfunction of the modular reverse diodes (DLA), a component in the equipment of the

Elekta Linear Accelerator, which have ruptured. Failures have occurred sometime after

beam termination.

M706 Ceodeux S.A.- Meditec 2011-06-27 2011-05-20 64095 Type II N/A M70600154 Discrepancy between some of the flow sets in valves manufactured between January 2009

and October 2010. This flow rate deviation may cause patients to receive a smaller or larger

dose of medicinal oxygen.

Getinge 8666-8668 Washer Disinfectors Getinge Disinfection AB 2011-06-27 2011-03-28 64502 Type II 8666, 8668 W50010963 There is an obvious possibility of inadvertently touching the non-protected electrical parts

while taking a water sample which can lead to a severe electric chock, potentially causing

serious injury.

Epidural Solution Administration Set Baxter Healthcare Corporation 2011-06-27 2011-06-03 64503 Type II 2C7554S GR293209 Baxter Corporation is recalling a single lot of the product because the position of the slide

clamp and roller clamp may have been reversed during assembly. The reversed orientation

of the slide clamp and roller clamp will cause the set to be incorrectly loaded into an infusion

pump, resulting in fluid flow from the patient to the pump, rather than from the pump to the

patient.

Reliance Vision SC Washer/Disinfector Steris Canda Corporation 2011-06-27 2011-05-09 63896 Type III FH05072 All Serial numbers Steris has learned through customer feedback that Vision SC Washers are experiencing

nuisance alarms and/or aborted cycles that are adversely affecting the reliability and

operation of their unit.

A) Oral / Enteral Syringe

B) Sample Pack Oral / Enteral Syringe

Philips Children's Medical Ventures 2011-06-27 2011-05-06 64039 Type III A) 1062680, 1062681, 1062682, 1062683

B) 1063224, 1078782



Affected Oral / Enteral syringes have a trace amount of nickel sulfide.

Aquilion 64 Toshiba Medical Systems Corporation 2011-06-27 2011-05-27 64174 Type II TSX-101A/H HCB1023750, HCB1083820,

HCB1083821, HCB10X3839

In the Aquilion System the following software issues have been noted: (1) The confirmation

may not be displayed properly during scanoscopy. (2) If the PGP hard split option is used

and the scano skip button is pressed, the second scanoscopy may not be completed. (3)

The use of PGP hard split may result in an error in image display processing. (4) If more

than 10 characters is entered in the image comment, the system software will terminate

abnormally. (5) Under certain circumstances if the helical skip button is clicked during one

of the scanning, the next helical scan may stop before it is completed.

SharePlan 1.1 RaySearch Laboratories AB 2011-06-27 2011-05-30 64415 Type III 1.0 Software version 1.3.1.10 Treatment plans with differing fraction sizes from certain versions of tomotherapy Hi*Art are

not recognized as having multiple fraction groups. It is also assumed that curves, calibration

depth and output factor depth all have the same offset.

LIASON 25 OH Vitamin D TOTAL Assay Diasorin Inc. 2011-06-27 2011-06-13 64628 Type II 310600 >10 Numbers, Contact Manufacturer In affected lots, recovery in plasma (EDTA, lithium heparin) specimens may exhibit on

average, a 36% positive bias (with a 95% confidence interval of 26% to 46%). Serum

specimens are recovering as expected.

GEM Premier 4000 System Instumentation Laboratory Company 2011-07-11 2011-06-02 64659 Type II 00025000000 06050100 to 11064853 Rare occurrences of falsely lowered K+ results (potential negative bias of 0.6 to 1.2 mmol/l)

can occur during cartridge life on patient blood analysis, leading to erroneous results with

potentially severe impact to patient treatment.

Langston Dual Lumen Pigtail Catheter Model 5515 Vascular Solutions, Inc. 2011-07-11 2011-06-07 64677 Type II 5515 548264 Addition of the Langston Dual-Lumen Pigtail Catheter, model 5515 lot# 548264 to the scope

of the previous field action 2134812-08/31/2010-001R as having a missing sterile barrier

pouch seal.

A) NexGen CKS Quick-Connect Handle

B) NexGn CKS Posterior Referencing Sizer

C) NexGen CKS Postier Referencing Sizer Boom

D) NexGen CKS Modular T-Handle

E) NexGen CKS Distal Femoral Resection

F) NexGen CKS Femoral Valgus Alignment

G) NexGen CKS Extramedullary Distal Telescoping

H) NexGen CKS Extramedullary Proximal Telescoping

I) NexGen CKS Extramedullary Modular Spike

J) NexGen CKS Patella Osteotomy Guide

K) NexGen CKS Patella Clamp

L) NexGen CKS Femoral & Provisional Impactor/Extractor

M) NexGen CKS Patella Peg Drill Guide


Zimmer Inc. 2011-07-11 2011-03-24 62538 Type II A) 00590103400

B) 00590104000

C) 00590104010

D) 00590106100

E) 00590106300

F) 00590106700

G) 00590107100

H) 00590107200

I) 00590107400

J) 00590301000

K) 00590302000

L) 00590102600

M) 00590306000

A) 61612789, 61682485, 61550601

B) 61558673, 61610687

C) 61558201

D) 61517185, 61609572

E) 61548704, 61615895

F) 61559529, 61625078

G) 61559187, 61633778, 61678730

H) 61543636

I) 61549223, 61593951

J) 61559367

K) 61555948, 61635432

L) 61522231, 61550613, 61637191, 61657309,

61659596

M) 61511575, 61542246, 61630733

Zimmer is initiating a recall of certain lots of NexGen Complete Knee Solution (CKS)

posterior referencing instruments (PRI) because they have a potential for exhibiting a

breakdown of the aluminum/titanium nitride PVD black coating. The NexGen PRI utilize this

coating as a cosmetic means to depict points of attachment or adjustment of the

instruments.

A) Signa HDX MR System

B) Discovery MR750 MR System

C) Discover MR450 1.5T MR System

GE Medical Systems LLC 2011-07-11 2011-06-10 64154 Type III A) M3335JA

B) M7000BH

C) M7000MJ

A) 1458927, 1469491, 1490961, 1537273

B) 1457924

C) 1496688, 1538397, 1590426

In the event of a significant power surge, such as one that might be caused by a lightning

strike or a utility equipment failure, there is a possibility that the fuse in the MRU (magnet

rundown unit) circuit could be affected. This situation could indirectly lead to a potential

hazard if an emergency magnet quench is required.

Vinci 600 System - Reciprocating Saw W&H Dentalwerk Burmoos GMBH 2011-07-11 2011-05-31 64424 Type II 17306210 01060, 01251, 01002, 01003, 01004 Following a complaint concerning the reciprocating saw attachment V600 SR (ref:

17306210), extensive tests have shown that in some cases screws can become loose or

might even come off (the attachment).

A) Versys Advocate Hip System, Femoral Stem

B) Versys Advocate Hip System, Femoral Stem, Extended

Offset

Zimmer Inc. 2011-07-11 2011-06-13 64816 Type II A) 00-7850-017-00

B) 00-7850-016-20

A) 60457914

B) 60530789

Certain lots of the Versys Advocate Hip System (Femoral Stem Cemented) may contain an

incorrect proximal centralizer packaged with the stem. The centralizer packaged with these

lots, if attempted to be used, may not mate properly with the stem.

A) StabilTube

B) E.T. Tape

C) E.T. Tape II

B&B Medical Technologies 2011-07-11 2011-04-14 63192 Type II A) BB11060

B) BB11020

C) BB11010

A) D024411, D029817

B) D025715

C) D033320, D036402, D102427

B&B Medical has been advised by the supplier of the skin prep pad, Smith & Nephew, that

due to manufacturing problems they are recallin g their skin prep products. The pads are

provided in each package of B&B Medical E.T. Tape.

A) Dyonics Power Shaver Blade-Full Radius

B) Dyonics Power Shaver Blade-Full Radius, Curved, Convex

Smith & Nephew, Inc., Endoscopy Division 2011-07-11 2011-05-12 63814 Type II A) 7205341

B) 7205336

A) 50561144

B) 50540107

Smith & Nephew has identified an issue with insufficient weld penetration which joins the

shaft tube and blade tip. This may cause the blade tip to separate from the tube shaft

during use.

Expression MRI Patient Montoring System-Main Unit Invivo Corporation 2011-07-11 2011-06-03 64640 Type II 865214 N/A During transport of the cart with a docked DCU, a front caster (wheel) may become loose

and fall off. If this occurs, the cart will become unbalanced and fall.

Zimmer Contoured Small Blade Zimmer Inc. 2011-07-11 2011-06-14 64817 Type III 00-7804-001-06 61494028, 61669212 Zimmer is initiating a recall of certain lots of the Zimmer Contoured Small Blade

instrumentation because the instruments within these lots contain a protruding weld that

may prevent the blade from sliding onto the corresponding retractor frame as intended.

A) Biopsy Site Identification Markers

B) Hologic Breast Biopsy Kit

Hologic, Inc. 2011-07-11 2011-04-11 63830 Type II A) CELEROMARK, TRIMARKTD-2S-13-12, TRIMARKTD-2S-13MR, TRIMARKTD-

2S-36-09

B) MME-00345

A) All lots

B) All lots

This recall is being performed due to the fact that the product is not licensed by Hologic in

Canada. The product is not defective in any way.

A) PK7300 Automated Microplate System - Instrument Class 3

B) Beckman Coulter PK7300 Automated Microplate System

(Donor Screening) - Instrument

Beckman Coulter, Inc. 2011-07-11 2011-06-02 64395 Type III A) PK7300

B) PK7300

A) All lots

B) All lots

The content of the PK7300 on-line help file and the PK7300 user's guide are different.

Change control is in place for hard copy versions of the user's guide and the local hard copy

is the primary reference for the operators. There is no assurance that the on-line version of

the user's guide has up to date "instructions for use" in all languages.

Impression Coping Open Tray CC NP 5 x 14mm Nobel Biocare AB 2011-07-11 2011-05-05 64562 Type III 36261 742552 Nobel Biocare has received complaints regarding an incorrect impession coping. After

investigation at Nobel Biocare Karlskoga it was discovered that the wrong label and color

coding has been used for one batch of the product impression coping open tray CC. The

information stated on the label is: Impression Coping Open Tray CC NP 5 x 14 mm (article

no. 36261. Lot 742552). The impression coping included in this package is impression

coping open tray cc rp 6 x 14 mm (article no. 36266).

Instruction for use for 45cm Laparoscopic

Instruments Sterilization Trays

Stryker Endoscopy 2011-07-11 2011-06-09 64651 Type II 0250-015-704 All lots During a review and retest of the sterilization parameters, Stryker Endoscopy discovered

that the 132OC gravity steam sterilization cycle did not consistently sterilize all of the

products in the tray.

SureSigns VS3 Philips Medical Systems 2011-07-11 2011-06-10 64855 Type II 863069, 863071, 863073, 863074 N/A Speakers on SureSigns patient monitors and vital signs monitors may fail prematurely. This

failure may be identified by the display of a "speaker malfunc" message in the alarm

message area or an "audio failed" message in the main screen of the device or by the

absence of audible sound.

Optima MR360 1.5T GE Hangwei Medical Systems Co. Ltd. 2011-07-11 2011-06-10 64935 Type III 5312366 (M50002BB) 1591211 Optima MR360 1.5T: in the event of a significant power surge, such as one that might be

caused by a lightning strike or a utility equipment failure, there is a possibility that the fuse

in the MRU could be affected. This situation could indirectly lead to a potential hazard if an

emergency magnet quench is required.

Xenon Universal Light Source Linvatec Corporation D.B.A. ConMed Linvatec 2011-07-11 2011-05-20 63916 Type III LS7700 72605 ConMed Linvatec has beed advised by a supplier that the power supply in the manufacture

of the lS7600 and lS7700 potentially has an unapproved component and may not meet

finished product requirements.

EZ-OX Plus Oxygen Regulator Vitalaire Canada Inc. 2011-07-11 2011-05-20 64020 Type II ALQ-2342 N/A One customer reported sudden and rapid emptying of an oxygen cylinder with the EZ-OX

Plus Oxygen Regulator. This was detected by the audibly loud noise of a pressurized

cylinder emptying rapidly.

Cook Sydney IVF Hyaluronidase Kits William A. Cook Australia, PTY. Ltd. 2011-07-11 2011-05-31 64304 Type III K-SIHY-1-5 A877629, A877483 Two lot numbers recalled in Canada due to the receipt of information that hyaluronidase

material of incorrect origin was used in the manufacture of the device.

Coherence Therapist Siemens AG 2011-07-11 2011-05-26 64362 Type III 8147667 10013, 10018, 071206-WI, P011206_R1, 11060 Sites with at least Primeview (R2.1 or 2.2) and RTT 4.1 connected to the same Lantis DB

(version 6.1 and 8.3) may observe concurrent DB access issues. In this case Primeview

displays an error message that informs the user about potential recording failures. A

segment recording failure with data loss might be the consequence.

Impax for Cardiology - Clinical Review Station AGFA Healthcare N.V. 2011-07-11 2011-06-08 64646 Type II 60+00007791 RM 2.04.37.04 to RM 7.8 SU2 When using the Impax CV reporting (RM) module, PDF renderings of final reports may be

inaccessible if a merge was performed on a previously signed report.

Impax Cardiovascular (CV) Admin Tool AGFA Healthcare N.V. 2011-07-11 2011-06-08 64647 Type II 60+00007791 Software Versions 1.00.26, 1.00.27, CV7.4.SU3, CV7.8If the end-user requests to move a report into a study that currently has a report associated

with it, the system will allow the move, however the result is that there is no indication that

the moved report exists when viewing the study through the user interface.

Impax for Cardiology AGFA Healthcare N.V. 2011-07-11 2011-06-08 64648 Type II 60+00007791 DICOMStore 2.04.44 and earlier AGFA initially identified the need for CRS upgrades when a customer in Canada, Edmonton

Cardiology Consultants, performed echocardiography volume measurements within CRS

that were not reflected correctly in associated results management (RM) reports. connexes.

Versafitcup Double Mobility Liner Inserter Medacta International SA 2011-07-11 2011-05-24 63981 Type III 01.26.10.0018 105549 One part of the instrument was made with wrong raw material, common steel instead of

stainless steel. A mistake by the raw material supplier that sent to Medacta's supplier, a

certificate for the stainless steel but with the wrong material. The supplier did not notice the

mistake and manufactured the entire lot. The wrong material was discovered to be used.

Axiom Artistos MX Siemens AG 2011-07-11 2011-05-31 64399 Type II 5895003 >10 Numbers, Contact Manufacturer Sites with at least Primeview (R2.1 or 2.2) and RTT 4.1 connected to the same Lantis DB

(version 6.1 and 8.3) may observe concurrent DB access issues. In this case Primeview

displays an error message that informs the user about potential recording failures. A

segment recording failure with data loss might be the consequence.

A) Artiste MV - Linear Accelerator - Syngo RT Therapist Assisit

B) Artiste MV - Linear Accelerator - Syngo RT Therapist


B) 08162815

A) 10024, 10048

B) 10040, 10003

There is a potential safety risk when delivering beams without imaging segments for which a

manual pause for the imaging segment is set. As a consequence of this risk the patient may

be injured or mistreated.

Leukosure Enumeration Kit Beckman Coulter, Inc. 2011-07-11 2011-06-01 64567 Type II 175621 5621012K, 5621013K, 5621014K There is incorrect activity levels stated on the instructions for use labeling in the Leukosure

Enumeration Kit due to the inaccurate activity values provided by the supplier for the raw

material ribo-nuclease a type III-A, utilized as a component of the Leukosure Stain Reagent.

The activity value for these lots is 3.25ku/ml, as compared to 4ku/ml as stated in the

product labeling. Alteration of the staining enumeration of white blood cells (WBC) in blood

component preparation might produce falsely high values of white blood cells in samples

with high levels of residual RNA. These high values may result in the the blood component

being considered inappropriate for use in transfusions, thereby reducing the availability of

blood for transfusion procedures. The high values may also result in unnecessary

reprocessing of the blood component.

Access Testosterone Reagent Pack and Calibrator Beckman Coulter, Inc. 2011-07-11 2011-05-23 64584 Type III 33560, 33565 All lots Beckman Coulter Inc. identified the following issue with the above listed products: 1. The

dilution recovery (linearity) data presented in the Access Testosterone instructions for use

(IFU) does not represent the current product performance. 2. In a recent study, thirty-four

(34) male serum samples with testosterone values from 4 to 10ng/ml were diluted 1/2 in

Access Testosterone Calibrator S0. The neat and diluted samples were then measured

using the Access Testosterone Assay. The calculated mean recover was 110% (range = 95

to 137%).

Brightview Gamma Camera System with 3/8" Crystal Philips Medical Systems (Cleveland), Inc. 2011-07-11 2011-06-17 64897 Type II 2170-3000A N/A There is a gap between the stationary portion of the table and the extendable patient pallet.

When the pallet is being translated patients' body parts (e.g. hair, skin, or fingers) or items

(such as clothes and IV tubing) may get caught between the stationary portion of the table

and extendable patient pallet if the instructions for use are not followed.

BD FACS 7-Color Setup Beads Becton, Dickinson and Company

BD Biosciences

2011-07-11 2011-05-20 64874 Type III 335775 83284, 87471, 02073, 02450, 02452, 02453 Sensitivity failures on BD FACS 7 Color Setup Beads, causing failure on the BD Facscanto

or Facscanto II Systems BD FACS 7 Colour Setup report.

ProTaper Universal Gutta Percha Dentsply Tulsa Dental Specialties, Trading as Dentsply

Endodontics

2011-07-11 2011-06-15 64898 Type III N/A 110381 The assortment packs of ProTaper Universal Gutta Percha points, item# PTUGPAST with

lot# 110381, may have the size F1 in the F5 slot and the size F5 in the F1 slot.

Acuson S2000 Siemens Medical Solutions USA, Inc. 2011-07-11 2011-06-15 64899 Type II 10041461 N/A Safety issue fix for VB10, VB10A, VB10B, VB10C systems. Meaurement results from a

previous study containing a patient report may be merged to the next patient study.

A) Avitene Microfibrillar Collagen, Web

B) EndoAvitene Microfibrillar Collagen

C) Syrine Avitene Microfibrillar Collagen

D) Avitene UltraFoam

E) Avitene Microfibrillar Collagen Flour

Davol, Inc., Subsidiary of C.R. Bard Inc. 2011-07-11 2011-06-24 64949 Type II A) N/A

B) N/A

C) N/A

D) N/A

E) N/A



C) WBRJFD43



The Avitene instructions for use (IFU) have been revised to include a warning or precaution

on the possible development of post-operative inflammatory reaction to the device,

including its clinical features and its timing.

Luminos DRF


Siemens AG 2011-07-11 2011-04-06 63437 Type II 10094200 2001, 1187, 2007, 2060, 2110, 2133 This update instruction provides multiple bug fixes and system improvements, such as,

enhanced direct radiation detection leading to wrong window values, wrong PEX-settings for

spatial frequency parameters leading to black images, imaging system crash with cancel of

reject analysis window, wrong flags in patient list, improvement of auto delete function,

improvement of error 3070/032, and improvement of error 7031/032.

Bond Max System-Usher2 (Oracle HER2 Bond IHC System) Leica Biosystems Newcastle Ltd. 2011-07-25 2011-05-23 65003 Type III TA9145 12135, 13341 Leica Biosystems recently became aware that there is a potential issue with the Bond

Oracle HER IHC System TA9145 lot numbers 12135 and 13341. They have become aware

of a potential occurrence of over-staining on procedural control cell-lines that are supplied

as part of the system. There is the possibility that the over-staining may be observed in in-

house tissue controls and/or patient tissue.

Ethernet-SATellite INterface (e-SAT/IN) Module Waters Corporation 2011-07-25 2011-06-13 65036 Type III 668000230 All lots The potential exists for data stored within the memory to be duplicated when uploaded to

the chromatography data acquisition computer. As a result, a previously reported section of

the chromatogram could be repeated.

Impression Matress Cover (Fire Barrier Option) Stryker Medical 2011-07-25 2011-05-27 64147 Type II 2980-000-000, 2980-000-002, 2980-000-004, 2980-000-006, 2980-000-008 All lots Stryker Medical has determined that some impression covers were manufactured with

bottom cover material that did not meet their specifications. As a result, some of the

impression mattresses with flame barrier option do not comply with the flame-retardancy

requirements, as specified in the code of Federal regulations.

Vitros Chemistry Products PHBR Slides Ortho-Clinical Diagnostics Inc. 2011-07-25 2011-06-27 65138 Type II 8221384 2532-0053-0217, 2532-0053-1490, 2532-0053-

4961,

2532-0053-0149, 2532-0053-4996, 2532-0053-

1488

Ortho-Clinical Diagnostics has received customer complaints of intermittent imprecision,

outliers or shifts in control fluid values when using various lots of Vitros Chemistry Products

PHBR Slides (phenobarbital) from coating 0053. The investigation confirmed that biased

values for patient samples could be obtained that may or may not be detected by quality

control fluids.

A) Seno Advantage 2.1 Volumeshare 2/4

B) Seno Advantage 2.2 Volumeshare 2/4

GE Medical Systems SCS 2011-07-25 2011-06-21 64537 Type II A) 5183685-X

B) 5342425-X

A) N/A

B) N/A

When Seno Advantage Workstation is synchronized with Radiology Information System

(RIS) using Clinical Context Object Workgroup (CCOW) (an Hl7 standard protocol designed

to enable disparate applications to synchronize in real-time), the following issues could

occur: 1. Two different patient images may be displayed at the same time. The Seno

Advantage Workstation may display one patient's multi-modality images on the 1 megapixel

(landscape) color monitor and another patient's mammography images on the 5 megapixel

(portrait) high-resolution black and white monitors. The patient name annotation is correct

whenever it is displayed on any monitor. 2. The patient images displayed on the Seno

Advantage high-resolution black and white monitors may not show images of the patient

selected on RIS and on the Seno Advantage color monitor. The patient name annotation is

correct whenever it is displayed on any monitor.

LifeCycle for Prenatal Screening Wallac OY 2011-07-25 2011-06-08 64569 Type II 5002-0020 v3.0 RevX, v3.1 Revv2 A false screening risk score can be potentially reported due to patient data overwriting.

Uplift Commode Assist Uplift Technologies Inc. 2011-07-25 2011-06-27 65162 Type II CA 200 1C0101 Plastic seat may not meet measurement specification. In these cases, the seat may not fit

the unit properly and may interfere with the unit's normal locking mechanism. There are

circumstances in which the seat could unintentionally begin to rise should it fail to lock as

intended.

J6-MI High-Capacity Centrifuge Beckman Coulter, Inc. 2011-07-25 2011-06-02 64583 Type III 360291, 360292, 360293 All lots Beckman Coulter Inc. has determined through ongoing quality assurance measures that the

J6-MI High-Capacity Centrifuge may be susceptible to electrostatic discharge during

operation.

A) Mantis System - Rod Inserter

B) Mantis System - Rod Inserter Inner Shaft

Stryker Spine SAS 2011-07-25 2011-06-14 64879 Type II A) 48284053

B) 48284052

A) All lots

B) All lots

Stryker has received reports of difficulty in rod rotation using the Mantis Rod Inserter. It was

reported that the Mantis Rod Inserter tip could disengage from the shaft.

Amplification Kit Ventana Medical Systems Inc. 2011-07-25 2011-05-27 64991 Type III 760-080 A02283 Amplification Kit, lot A02283, has a reagent registration button that contains incorrect

expiration dating information. As a result, after scanning the registration button information

into instrument, the kit will only provide a useful life through 19-July-2011. The date should

have been 27-Dec-2011.

Leksell Gamma Knife C1.2, 4 and 4C Elekta Instruments AB 2011-07-25 2011-05-26 65089 Type II 912800 4310 The actuator that operates the helmet hoist has a limited life span and may fail.

Discovery CT750 HD Computed Tomography X-Ray System GE Medical Systems, LLC 2011-07-25 2011-03-23 65178 Type III B7877HD N/A Ge Healthcare has become aware that scan will not complete if Smartprep is used in

combination with new GSI presets GSI-31, GSI-32, GSI-33, or GSI-34 on Discovery CT750

HD Systems.

Minutex D-Dimerkit, Part No. 150707 Tcoag Ireland Limited 2011-07-25 2011-06-02 65192 Type II 150707 C040002, C042002, B218005, B341002,

B144001

The latex reagent component of the test kit fails to cause agglutination in patient samples

containing levels greater than 250 ng/ml of D-Dimer. The failure will give a false negative

result for the test.

Aqarius Software V. 4.01.11/4.01.12 Baxter Healthcare SA 2011-07-25 2011-06-29 65217 Type II GEF08200 .0698, .0700, .0757, .0779, .0927, .0940, .0941,

.0970, .1467

Baxter Corporation, the current device licence holder, is providing a follow-up to earlier

notices from Edwards Lifesciences, the previous device licence holder, concerning Edwards

Aquarius software versions 4.01.11 and 4.01.12, and reports of significant fluid imbalance in

patients, related to repeated overriding of the fluid imbalance alarms of the Aquarius system

software, contrary to the operating manual of the device.

HLA Fusion Software, version 2.0.0-SP1,

RSSOH1AC_Update.exe

One Lambda Inc. 2011-07-25 2011-01-17 62661 Type II N/A version 2.0.0 SP1, RSSOH1AC The use of HLA Fusion version 2.0.0-SP1, RSSOH1AC_update.exe with analysis of

following kits/products may cause a conversion error giving incorrect test results.

A) Eclipse Ocular Proton Planning V1.1

B) Eclipse Smart Segmentation

C) RapidArc, also known as Dose Dynamic Arc / Volumetric

Modulated Arc Therapy

Varian Medical Systems, Inc. 2011-07-25 2011-04-04 63895 Type II A) TPA001075000

B) TPA001094000

C) UP9001

A)>10 Numbers, Contact Manufacturer /


B) H484530, H484531, H484526, H484527,

H484528, H487407

C)>10 Numbers, Contact Manufacturer /


There is an anomaly in Eclipse versions 8.0 to 8.6 whereby a particular plan approval

workflow may result in a difference between the intended SSD value and the SSD value

communicated to the treatment delivery system.

Cypher Select Plus Sirolimus-Eluting Cordis Europa N.V. 2011-07-25 2011-06-29 65225 Type II CRB28225, CRB28250, CRB28275, CRB28300, CRB28350, CRB33225,

CRB33250, CRB33275, CRB33300, CRB33350

>10 Numbers, Contact Manufacturer Cordis is informing customers that there is a possibility of having units within the distributed

lots of Cypher Select Plus Sirolimus-Eluting Coronary Stent (catalog numbers CRB33XXX

and CRB28XXX) that may not meet the Cordis internal design specification for stent

expansion uniformity (SEU). The SEU acceptance criterion for Cypher product is less than

10 percent.

24k Arthroscopy Outflow/Suction Tubing Set Linvatec Corporation D.B.A. Conmed Linvatec 2011-07-25 2011-07-05 65301 Type II N/A >10 Numbers, Contact Manufacturer There is a possibility that certain lot numbers of the 24k100, 24k Arthroscopy

Outlfow/Suction Tubing Set may have a breach in the tyvek pouch, thereby potentially

compromising the sterility of the device.


B) Synchron LX20 System Analyzer - Class 3

C) Synchron LXI 725

D) Synchron LX20 PRO

Beckman Coulter, Inc. 2011-07-25 2011-04-18 63157 Type II A) N/A

B) N/A

C) N/A

D) N/A

A) All lots

B) All lots

C) All lots

D) All lots

The current access and DXI instrument manuals specify an unrestricted ambient operating

temperature range of 18ºC to 32ºC. Some access immunoassays are affected by ambient

temperature changes and can produce inaccurate results when a system is operated within

the published range.

A) VectorVision Navigation Software ENT 7.9

B) Kolibri ENT 2.7/ENT Essential 1.0/ENT Unlimited 1.0

Navigation Software

C) Kolibri 2.7/Essential 1.0/Unlimited 1.0/VectorVision 7.9

Cranial Navigation Software

Brainlab AG 2011-07-25 2011-06-10 65093 Type II A) 22076G::VV NAVIGATION SW, 71068::UPDATE VV NAV SW E

B) 22201F::KOLIBRI NAVIGATION, 22211::ENT ESSENTIAL NAVI, 22212::ENT

UNLIMITED NAVI, 71015::UPGRADE VV ENT 7.9, 71072::UPD KOLIBRI NAV

SW

C) 22040G::VV NAVIGATION SW, 22204E::KOLIBRI NAVIGATION,

22207::CRANIAL ESSENTIAL, 22208::CRANIAL UNLIMITED, 71011::UPG CRA

ESSENTIAL, 71012::UPGRADE VV CRANIAL, 71067::UPDATE VV NAV SW C,

71077::UPG CRA UNL 1.0 FR,

A) N/A

B) N/A

C) N/A

In the surface matching registration dialogue, if "last solution" after acquisition of additional

registration points is selected, the software stores a different registration than the one

displayed to the user for verification.

Medrad Veris Temperature Sensor Probe Medrad Inc. 2011-07-25 2011-06-06 65096 Type II 3011996W >10 Numbers, Contact Manufacturer It was discovered that when the impacted temperature sensors are attached to the Veris

monitor, the error message 'bad probe' is displayed.

A) Avanta Fluid Management Injection System - Main Unit

with Pedestal

B) Avanta Fluid Management Injection System - Main Unit

with Table Mount

Medrad Inc. 2011-07-25 2011-06-02 65097 Type II A) AVA 500 PDL

B) AVA 500 TBL

A) 20191, 20208

B) 10434, 10458, 10459, 10460, 20017, 20023,

20051, 20145, 20370, 20570

There is a software upgrade to the Medrad Avanta Fluid Management Injection System, the

upgrade includes the dual line purge software (formerly known as one-touch purge software).


B) Trilogy Radiotherapy Delivery System

C) Clinac IX Radio Therapy Delivery System

D) Novalis TX Linear Accelerator

Varian Medical Systems, Inc. 2011-07-25 2011-03-28 65193 Type II A) Clinac Linear

B) Trilogy

C) Clinac IX

D) Novalis TX



B) H291166, H293787, H294551, H140836,

H294134, H293883, H291172, H294934,

H294403, H294750

C) >10 Numbers, Contact Manufacturer /


D) H294674

An anomaly has been identified whereby, following prolonged use, the screw fastener

holding the wedge body to the tray may fail. The falling wedge presents a risk of injury to

patients or other personnel in the path of the falling wedge. The risk of failure is

proportional to the amount of use of the wedge, and is considered significant only after

many years of use. The risk is also increased for heavier wedges, upper wedges used in

the interface mount, and for wedges where the screw fasteners are loose or have a history

of becoming loose. Varian is aware of this occuring only for 30 degree upper wedges.

Other wedges may potentially be susceptible to the same failure.

Optical Guidance Platform - SonArray Module Varian Medical Systems, Inc. 2011-07-25 2011-03-28 65193 Type II 97530203A HZ19078, HZ12066, NZ17010 The Optical Guidance Platform may not be properly enforcing a 24 hour time limit between

optical camera recalibrations. The optical guidance camera has not been evaluated for

stability beyond a 24 hour time period and must be recalibrated at least once every 24

hours. This issue is most likely to be found in units upgraded to the 2.6.x software as older

versions of the software allowed users to set calibration time outs greater than 24 hours.

However, all users should check their settings as described. In particular, this issue may be

found in SonArray Systems where users may have increased the calibration time out

beyond the factory settings.

Aria Practice Management -

4D Integrated Treatment Console (4DITC)

Varian Medical Systems, Inc. 2011-07-25 2011-05-27 65197 Type II V8.1.2, V8.6, V8.8 >10 Numbers, Contact Manufacturer /


Under certain specific circumstances, the gantry rotates in the opposite direction to that

specified according to the plan parameters, when moving from one field to the next. If the

patient couch or other medical equipment is in the path of the gantry, damage to property or

injury to a patient could occur. According to Varian IEC scale, the gantry will rotate

clockwise (CW) from 0.0 degrees to 180.0 degrees and counterclockwise from 0.0 degrees

to 180.0E degrees. By default, when a user creates an opposing field within a plan that

contains static fields, the gantry rotation is set to rotate in the clockwise direction. For

situations when that is not desired, a user activated extended angle flag is provided to

cause the gantry to rotate in a counterclockwise direction.

A) On Board Imager

B) TrueBeam (Radiotherapy Configuration)

Varian Medical Systems, Inc. 2011-07-25 2011-06-21 65263 Type II A) OBI

B) TRUEBEAM



B) H191038, H191071, H191044, H191069

An anomaly has been identified in the 3D match environment of OBI 1.3, OBI 1.4, OBI 1.5,

TrueBeam 1.0 and offline review 1.0 - 2.0 when using reference CT datasets which contain

a critical number of slices. [note that the 3D match environments of TrueBeam 1.5 and

offline review 2.1 are not affected by this anomaly.] When these reference CT datasets are

used to create a reference CT volume in the 3D match environment, in a small number of

cases, the scaling of the CT volume will be incorrect and the CT volume will appear larger -

in the slice direction - than it actually should be. If this improperly scaled CT volume is used

for 3D matching, the CBCT volume and patient may be positioned too far superiorly.

Because of differences in software design, OBI 1.5 is much more likely to exhibit this

behaviour than the other products identified.

A) Mystic II Pump with M-Style Mushroom Cap

B) Mystic II Pump with Mitysoft Bell Cup

Coopersurgical Inc. 2011-07-25 2011-06-29 65406 Type III A) 10057

B) 10058



B) >10 Numbers, Contact Manufacturer /


Certain devices may be unable to create a vacuum due to a component fit that potentially

could result in a leak.

A) Clinac IX High Energy Linear Accelerator

B) Trilogy High Energy Linear Accelerator

C) Novalis TX High Energy Linear Accelerator

Varian Medical Systems, Inc. 2011-07-25 2011-03-31 65449 Type II A) N/A

B) N/A

C) N/A

A) H294383, H294766, H294675, H294683,

H294838, H294317, H294364

B) H294551, H140836

C) H294674

Due to mechanical strain on the coolant line, the coolant system gantry swivel joint may

leak into or near electrical components within the gantry or gantry stand housing, creating

an electric shock hazard to personnel working within the gantry fiberglass housing, and

possibly leading to the failure of the device to operate.

Universal Urinary Incontinence Sling Generic Medical Devices, Inc. 2011-07-25 2011-03-15 62622 Type II 1010 >10 Numbers, Contact Manufacturer /


Model 1010 sling assembly's sheath and mesh/sheath/sleeve bonding area design may

have caused or contributed to certain adverse events, including voiding

dysfunction/retention, which in some cases required sling revision or removal.

Synchron LX Systems APO-B Reagent Beckman Coulter, Inc. 2011-07-25 2011-05-02 63541 Type III 467905, 469170 M001724, M009389 Quality control ranges would shift up for Apolipoprotein B (APOB) reagent lots M011619 and

newer with APO CAL (Apolipoprotein calibrator) lots listed.

XPRT Advanced Pulmonary Therapy Surface Stryker Medical 2011-07-25 2011-06-20 64895 Type III 2950-100-002 XPTG01048 Stryker Medical has discovered that the one-way valve in the EPRT Mattress may have

been installed incorrectly and has the potential to result in air escaping out, causing the

mattress to sag when weight is placed in the centre.

Delfia Xpress 6000 Immunoanlyzer System - Free HCGB

Assay

Wallac OY 2011-07-25 2011-06-24 65168 Type III 6002-0010, 6002-001C 1060930001, 1060818901, 1060877201,

1060851601, 1060936301,1060947501,

1060857901, 1060931801

Incorrect labeling on some vials of Free HCGB Calibrator C in lot 607826, a component in

the affected pack lots.

Biometer LS 900 Lenstar Haag-Streit, AG 2011-07-25 2011-06-21 65175 Type II 7220096 NAV, 00070, 00094 Due to two software programming errors (version I2.000 and I3.000), a patient record will be

linked to an incorrect / inconsistent set of calculation results under specific circumstances.

Skin-Prep Protective Wipes Medtronic Xomed Inc. 2011-07-25 2011-06-17 65179 Type II 1528116, 1528126, 1528136,

1529100, 1529110, 1529120

N/A Medtronic Xomed is expanding the original product safety advisory for Medtronic External

Nasal Splints and Thermasplints (incident 62165) to advise consignees to immediately

discontinue using and dispose of the Skin-Prep Protective Wipes packed together with the

affected Medtronic Nasal Splint Kits. The Smith & Nephew Skin-Prep Protective Wipes are

contract manufactured by the Triad Group in the same facility where the alcohol wipes,

subject to the original field action, are manufactured.

Merogel Injectable Anika Therapeutics S.R.L. 2011-08-08 2011-03-11 62260 Type II 15-18000 32300, 31700, 31900, 32000, 32100 Unclear labeling on the product due to the use of an incorrect sterility symbol.

A) Magnetom Aera

B) Magnetom Skyra


B) 10432915

A) N/A

B) N/A

This update instruction will help to recognize faulty gradient cable connections and

subsequently prevent those from overheating. As part of the UI, thermal sensors (self-

adhesive labels) will be attached to the connections identified as critical.

A) Hitachi Phosphorus

B) Hitachi Unsaturated Iron-binding Capacity (UIBC)

Roche Diagnostics GMBH 2011-08-08 2011-06-29 65098 Type III A) 11489348216, 11730347216, 11875949216, 11875965216

B) 04361563190, 12146282216, 12146398216

A) All lots

B) All lots

The manufacturer has implemented a new onboard stability for some modular analytics

reagents (phosphorus, UIBC) as a harmonisation process in order to standardise the open

reagent container for all Roche analyzers. The package inserts of the identified products will

be modified accordingly.

Symbia T Siemens Medical Solutions USA, Inc.

Molecular Imaging Group

2011-08-08 2011-06-22 65177 Type II 10275010 N/A There is a potential patient safety issue when using the Symbia Radiation Therapy Pallet

(RTP). The issue occurs when a patient is not ISO-centred before starting a scan and a non-

circular orbit is selected.

Optical Guidance Platform - Optical Positioning System Varian Medical Systems, Inc. 2011-08-08 2011-03-03 65195 Type II 97525005A HZ19078, HZ12066, HZ17010 The initial date assigned to the plan is the date of the data transfer. This date is updated

when any 'new' file is written into the directory. This date may change when performing

other functions with a transferred patient file such as saving pre- recorded positions, fiducial

registration, and report or patient settings. Therefore, exam transferred at time 'T' but

opened for a quick review in 'T'+T may have the later timestamp leading to confusion at the

time of exam selection. The risk is a user opens a previous exam for review and then

'saves' the file. They then go to open today's exam, however they select the most recent

exam (the one they just opened, reviewed, and saved) thinking it is treatment plan for the

day when it is not.

Synchron Systems Rheumatoid Factor (RF) Reagent Beckman Coulter, Inc. 2011-08-08 2011-06-24 65464 Type II 475136 All in-date lots The all in-date lots of Synchron Rheumatoid Factor (RF) Reagent might generate false

positive results or calibration failures.

HL-20 Perfusion System - Consoles Maquet Cardiopulmonary AG 2011-08-08 2011-06-29 65466 Type II 706187, 706189, 706193, 706195, 706197,

706199

>10 Numbers, Contact Manufacturer During cleaning or desinfecting, it is possible for liquids to enter into the HL 20 - 4 pump

console or HL 20 - 5 pump console. If an excessive amount of liquid is used, the liquid can

accumulate inside the HL 20 console and drip onto the HL 20 power supply board where it

might cause the power supply board to malfunction.

HL-20 Perfusion System - Roller Pump Modules Maquet Cardiopulmonary AG 2011-08-08 2011-06-29 65469 Type II TPM 20-330 >10 Numbers, Contact Manufacturer In very rare cases, it is possible for a HL 20 twin pump module (TPM) to unintentionally

increase its speed for a 1.5 - 2 second period of time before returning to its originally set

speed. This malfunction can only occur when the TPM is used for cardioplegia and set up in

a master/ slave configuration. During the malfunction, a very transient incorrect mixing of

the cardioplegia solution can occur before the pump speed returns to its original setting.

This behavior can only occur when one of the TPM pumps is set as cardioplegia slave and

the as cardioplegia master pump. When the TPM is used in any other confirguation, this

malfunction does not occur.

Beckman Coulter PK7300 Automated Microplated System

(Donor Screening) - Instrument

Beckman Coulter, Inc. 2011-08-08 2011-06-27 65471 Type II PK7300 9010177 The 2 struts (part # MF0285 downstay) that support the PK7300 cover while in the open

position may weaken allowing the cover to fall and strike the analyzer operator.

STiK! Etch Synca Marketing Inc. 2011-08-08 2011-06-07 65543 Type III SYN/STK12 3505084, 3490709, 3490709, 3490709 The product contains a higher percentage of phosphoric acid than what is mentioned on the

label. The product also continues to extrude from the syringe after pressure is no longer

applied.

Interlink, Non-DEHP IV Catheter Extension Set Baxter Healthcare Corporation 2011-08-08 2011-07-08 65550 Type III 2N3375 UR09H05029 Baxter Corporation is issuing a recall for a single lot of the Interlink system Non-DEPH IV

Catheter extension set, as a limited number of individual packages were improperly sealed,

which could lead to a compromise in the sterile properties of the packaging.

V-CATH PICC SL Tray Catheter Neo Medical, Inc. 2011-08-08 2011-04-12 64396 Type II 301-00 2009092850, 2010012950, 2010030150,

2010043050, 2010061850, 2010062950,

2010082650

Vials may contain visible particles.

A) Level 1 Normothermic IV Fluid Admin. Sets

B) Level 1 F-50 Gas Vent Filter Assembly

Smiths Medical ASD Inc. 2011-08-08 2011-06-21 64851 Type II A) DI-150, DI-350, DI-65HL, DI-75

B) F-50


B) 1851840, 1904351

Smiths Medical is recalling all level 1 Normothermic IV Fluid Administration Sets equipped

with the F-50 gas vent filter assembly (GVFA) from the market and temporarily suspending

all sales of these products because of complaints of kinking of the tubing and leaking of the

F-50 GVFA. In some cases, kinking in the tubing or leaking of the F-50 GVFA can cause a

decrease in fluid flow rate.

Optical Guidance Platform - Optical Positioning System Varian Medical Systems, Inc. 2011-08-08 2011-03-30 65196 Type II 97525005A HZ19078, HZ12066, HZ17010 An anomaly has been identified with the Optical Guidance Platform (OGP) software v2.6

and v2.6.1. this defect causes LAT error of 0.8mm - 1mm for datasets arriving to Optical

Guidance Platform (OGP) from eclipse and other planning systems in the left side first

orientation. This issue is only applicable to sites using direct eclipse or other non fastplan

3rd party treatment planning software that send data in true dicom format. This issue

affects body array, frameless array and frameless array SRS.

CADD-Solis Ambulatory Infusion Pump Smiths Medical ASD, Inc. 2011-08-08 2011-07-04 65303 Type II 21-2101-0200-02, 21-2101-51, 21-2102-51, 21-2111-0100-51, 21-2111-0200-02 >100 Numbers, Contact Manufacturer Smiths Medical is providing a safety alert to advise its customers of the attached customer

information bulletin 05-05-11, that provides additional information for correctly latching the

CADD Medication Cassette Reservoir or administration set to the pump. Smiths Medical has

become aware of small number of complaints of significant under-delivery/non-delivery of

fluids when the cassette is not correctly latched to the pump.

Epidural Solution Administration Set

Updated recall # 64503 previously posted on 2011-06-27. /

Mise à jour du retrait # 64503 affiché le 2011-06-27.

Baxter Healthcare Corporation 2011-08-08 2011-06-03 64503 Type II 2C7554S GR293209, GR291559 Baxter Corporation is recalling a single lot of the product because the position of the slide

clamp and roller clamp may have been reversed during assembly. The reversed orientation

of the slide clamp and roller clamp will cause the set to be incorrectly loaded into an infusion

pump, resulting in fluid flow from the patient to the pump, rather than from the pump to the

patient.

Lantis Siemens AG 2011-08-08 2011-06-30 65472 Type II 4503178 N/A When using sequencer with the Lantis Oncology Information System, the error comes up if

Lantis cannot insert a new record.

Intellivue Clinical Information Portfolio Philips Medizin Systeme Boeblingen GMBH 2011-08-08 2011-07-11 65590 Type II N/A N/A Philips has become aware that under certain circumstances, edits to an order can result in

unintended scheduled interventions on the Intellivue Clinical Information Portfolio. If the

clinical team does not recognize that such unintended interventions are scheduled in ICIP

order management, a patient may receive interventions or additional medication doses that

are not intended.

EasyDiagnost Eleva Philips Medical Systems DMC GMBH 2011-08-08 2011-07-13 65596 Type II 426058 N/A Due to a software anomaly, the camera may intermittently shut off causing a loss of

fluoroscopy, resulting in an interruption of the examination.

Flexitron HDR Afterloader Nucletron B.V. 2011-08-08 2011-06-01 65038 Type II 136149A01 N/A In the service mode, the "source alignment procedure" can be started with the door

physically open as well as with the doorswitch on Linac. This could potentially expose the

operator to radiation.

A) Sofsilk Non-Absorbable Silk Sutures

B) Ticron Non-Absorbable Polyester Sutures

Covidien LLC 2011-08-08 2011-06-07 65090 Type II A) 2-0 (GS62M), 3-0 (GS33M), 3-0 (GS63M)

B) 3259-62 (8886325962)

A) N/A

B) N/A

Potential for the sterile barrier to be compromised.

SoftPath GUI v. 4.3.0.10-11-12 SCC Soft Computer 2011-08-08 2011-07-07 65682 Type II 566698 N/A When the contents of faxed reports have been verified, they found one of the specimen

diagnosis to be missing. Parts A through D were present as well as part F, however part E

diagnosis was missing.

Theralite High Cut-Off Dialyzer Gambro Dialysatoren GMBH 2011-08-08 2011-07-15 65588 Type III 113092 1-082 Some units of Theralite High Cut-off dialyzer from lot1-082 may have an incomplete seal of

the sterile bag. It is possible that a compromised sterile barrier could go unnoticed and an

unsterile product could be used on a patient.

EndoPlege Coronary Sinus Catheter Edwards Lifesciences LLC 2011-08-08 2011-07-11 65591 Type II EP >10 Numbers, Contact Manufacturer Edwards Lifesciences has become aware of possible separation of the Introducer Sheath

from the hub. The Introducer (IntroCSC) is packaged with the EndoPlege Coronary Sinus

Catheter (EP). If the sheath becomes detached from the hub, surgical intervention may be

required to retrieve the sheath.

A) Rusch Female Catheter

B) Robinson/Nelaton PVC Catheter

Teleflex Medical 2011-08-08 2011-07-11 65593 Type II A) 238300080, 238300100, 238300120, 238300140, 238300160

B) 238500100, 238500120, 238500140, 238500160, 238500180, 238500200,

238500220, 238500240



The urology catheters are being recalled because the packaging may be compromised and

therefore the sterility of the product cannot be guaranteed.

Architect System - C-Peptide Assay ABBOTT LABORATORIES DIAGNOSTIC DIVISION 2011-08-08 2011-07-12 65594 Type II 03L53-25 01711A000 C-Peptide lots have the potential to generate falsely elevated results with certain patient

samples and with non-Abbott controls. Abbott controls are not impacted.

A-dec 311 Dental Chair A-dec, Inc. 2011-08-08 2011-03-03 65645 Type II 311 N/A A-dec inc received reports indicating articulating headrests had failed. The company found

out that the mechanism of the headrests may fail, potentially causing a sudden and

unexpected loss of holding force.

Panocell-16 Immucor Inc. 2011-08-08 2011-07-18 65738 Type II 2332 24019 There is a typographical error on the supplemental unconfirmed typings for Cell 9 (donor

b1356). The donor is listed as RG+ and should be listed as RG-. The accompanying master

list correctly lists Cell 9 as RG- in the Special Type column.

A) Elecsys Ferritin

B) Online TDM Carbamazepine (CARB2) for Cobas C System

Roche Diagnostics GMBH 2011-08-08 2011-05-06 63730 Type III A) 03737586190

B) N/A

A) 16095101, Specific Shipment Only

B) 63884401, Specific Shipment Only

A small temperature deviation that was observed with two products during transportation.

The temperature decrease was shown to come from some dry-ice shipments.

Ultra View Universal DAB Detection Kit Ventana Medical Systems Inc 2011-08-08 2011-05-16 64948 Type II 760-500, ROCHE CAT # 05269806001 A05885, B00988 Ventana Medical System Inc has identified the presence of precipitates in DAB Chromogen

Dispensers associated with Ventana DAB Detection kits. It may result in light to no staining

on some slides which could result in a false negative diagnosis.

A) Cobas Integra System - Salicylate

B) Roche Hitachi / Salicylate

C) SALI (Salicylate for Roche/Hitachi Cobas C311 and

C501/502 Systems)


B) 11815172216

C) 20753580322

A) All lots

B) All lots

C) All lots

Update the interference claims of the Salicylate Assays for use on Cobas Integra,

Roche/Hitachi and Cobas C Analyzers.

A) Eclipse Ocular Proton Planning V1.1

B) Eclipse Smart Segmentation

C) Rapidarc, also known as Dose Dynamic Arc

D) Eclipse TPS V8.8

Varian Medical Systems, Inc. 2011-08-08 2011-05-03 65752 Type II A) TPA001075000

B) TPA001094000

C) UP9001

D) 100042024




D) H48A478, H48C062, H48C063, H48A242

An anomaly has been identified with certain AAA versions where the second source

modeling for IMRT fields with Multiple Carriage Groups is incorrect. In affected AAA

versions when modeling the second source, the Collimator Jaw positions are read from the

first control point of the field. This can cause an underestimation of the dose when

calculating an IMRT field which has Multiple Carriage Groups. When the plan is delivered

the delivered dose can be higher than planned locally by up to 10%.

Cuff-Able Blood Pressure Cuff Vital Signs Inc. 2011-08-08 2011-07-08 65773 Type II All, BP101020, BP101520, BP101720, BP102020, BP151020, BP151520,

BP151720, BP152020, BP201020, BP201520, BP201720, BP202020

N/A The Blood Pressure (BP) cuffs may not properly inflate due to a leak.as a result, the BP cuff

may indicate an incorrect blood pressure reading.

A) Cuff-Able Blood Pressure Cuffs

B) Broselow/Hinkle Pediatric Emergency System Kits -

Oxygen Masks

C) Broselow/Hinkle Pediatric Emergency System Flying

Carpet - Cuffable BP Cuffs

D) Broselow/Hinkle Pediatric Emergency System Oxygen

Delivery Module - Oxygen Masks

E) Broselow/Hinkle Pediatric Emergency System Pouch, Bag

and Tag Pack - Cuffable BP Cuff

Vital Signs Inc. 2011-08-08 2011-07-08 65774 Type II A) BP4030BR

B) 7730ALS, 7730BLU5, 7730GRN5, 7730IALS, 7730MOD, 7730ORG5,

7730PUR5

C) 7730FLY

D) 7700BAW2, 7700GAW2, 7700OAW2, 7700PAW2, 7700RAW2, 7700WAW2,

7700YAW2

E) 7730POCH

A) N/A

B) N/A

C) N/A

D) N/A

E) N/A

The manufacturer of the oxygen mask, UnoMedical, conducted a field corrective action to

address a potential sticky substance on the inside and/or outside of the mask, included in

the vital signs Broselow Pediatric Emergency System kit. Blood pressure cuffs also included

in the vital signs Broselow Pediatric Emergency System kit may not properly inflate, which

may result in an incorrect blood pressure reading.

Aria Software Varian Medical Systems, Inc. 2011-08-08 2011-05-17 65826 Type II N/A HIT0040, HIT0606M, HIT0606R1, HIT2414M,

HIT2414R1

Using the RT chart function in Aria, versions 8.0 and 8.1 when users select the "convert to

set-up field" option, a set-up field is created, that removes the DMLC (Dynamic Multi Leaf

Collimator) plan components in order to create an open collimator for field light setup

purposes. In a recently reported case, a user, having selected this option in error, then

converted the setup field back to a treatment field. The resulting treatment field is then

missing the DMLC. If this error is not detected prior to patient treatment, open field

treatment can result.

A) Elucigene CF-EU1

B) Elucigene CF29 w/o TAQ - 50 Test Kit

C) Elucigene CF-EU2 - 50 Test Kit

D) Elucigene CF-EU2 - 10 Test Kit

E) Eluciegene TRP - 50 Test Kit

Gen-Probe Life Sciences Ltd. 2011-08-08 2011-06-10 64649 Type II CF1EUB2, YF029B2, CF2EUB2, CF2EUBX, TH003B2 N/A The devices were imported into and/or sold in Canada prior to receiving regulatory approval

by Health Canada.

Luxstar Dental Light Dental Equipment LLC. DBA Marus 2011-08-08 2011-06-24 65582 Type III N/A ML1000, OL1000, CL1000, UL1000, TL1000 Dental Equipment LLC Marus became aware via 16 external failures that the Lens Heat

Sheild (Birdcage) could fail and injure a patient if not properly installed or maintained.

A) CD Horizon Legacy Multi-Axial Screw

B) Vertex Cortical Screw

Medtronic Sofamor Danek USA, Inc. 2011-08-08 2011-07-08 65589 Type II A) 75445540

B) 69004440

A) H09E6272

B) H05J2843

Medtronic has initiated a recall of two lots of Pedicle screws used for spinal surgery because

they were etched with the wrong screw length. It was discovered that the screws are actually

longer than the etching states. The error was determined to be due to human error in the

manufacturing process.

Infusable Pressure Infusor Vital Signs Inc. 2011-08-08 2011-05-17 65772 Type II IN800012, IN900012, IN950012 N/A The Infusors may leak and not apply the desired pressure to the I.V. solution bag and

subsequently the rate of infusion may be inadequate. If used in conjunction with an arterial

pressure line for the purpose of measuring blood pressure, a potential falsely low blood

pressure reading may result. This issue may impact patient safety.

Becton Dickinson 1ml 28g Insulin Syringe with Needle Becton Dickinson and Company 2011-08-08 2011-06-17 65794 Type III N/A 39920 Becton Dickinson has determined that a quantity of product, packaged within experimental

shelf cartons made of recycled cardboard, was released to consumers within Lot 0039920.

Each of the experimental shelf cartons is labeled with an orange "change control" sticker,

identifying it as the experimental material. Note: only the outer packaging, shelf carton

material was "experimental". The actual syringe products, and inner sterility barrier

packaging, were all the correct, qualified materials.

MadaJet XL Part Number 601-0000 Ormco Corporation 2011-08-08 2011-07-01 65825 Type III N/A 601-0000 The recall was initiated at the request of Health Canada because Ormco Corporation was

unable to provide data which would assure the product's sterility as per the sterilization

methods detailed in the instructions for use.

12-Lead ECG cable Physio-Control Inc. 2011-08-22 2010-05-24 64026 Type II 11111-XXXXXX 3302822-000-AHA, 3302822-002-AHA, 3302822-

001-IEC, 3302822-003-IEC, 3302823-000-AHA,

3302823-001-IEC

The purpose of this field action is to notify customers who own 12-lead ECG cables that

were distributed between October 5, 2010 and May 3, 2011 of important storage and

handling instructions. The notification letter will bring attention to and provide storage and

handling instructions to users.

A) RAPIDpoint 400 System

B) Blood Gas System-Control Reagents

C) 840/845 Blood Gas System-Control Reagents

D) 348 System-Reagents

E) 860/865 Blood Gas System-Control Reagents

F) RAPIDQC Complete Level 1

G) RAPIDQC Complete Level 2

H) RAPIDQC Complete Level 3

Siemens Healthcare Diagnostics Inc. 2011-08-22 2011-06-13 64866 Type III A) 108860, 108868, 108869

B) 108860, 108868, 108869

C) 108860, 108868, 108869

D) 108860, 108868, 108869

E) 108860, 108868, 108869

F) 108860

G) 108868

H) 108869

A) 361004, 362003, 362004, 363003

B) 361004, 362003, 362004, 363003

C) 361004, 362003, 362004, 363003

D) 361004, 362003, 362004, 363003

E) 361004, 362003, 362004, 363003

F) 361004

G) 362003, 362004

H) 363003

There is an error in the package insert pertaining to the Co-Oximeter parameters of the

RAPIDQC Complete controls. RAPIDpoint 405 system values and barcodes were

transposed with those of the RAPIDlab 800 series system. RAPIDlab 1200 system values

for neonatal bilirubin are incorrect.

LIFEPAK 500 Automated External Defibrillator Physio-Control Inc. 2011-08-22 2011-06-17 64896 Type II 3005332, 3005335, 3005338, 3005339, 3005343, 3005379, 3005380, 3005381-

000, 3005381-001, 3005381-002, 3005389, 3005400, 3005578, 3006007,

3006535, 3009767, 3010697, 3010698, 3010779, 3011019-000, 3011020,

3011111, 3011520, 3011790, 3200390, 500, 803499-00, 803499-09, 805662

>100 lot numbers Contact Manufacturers A field alert regarding apotential reliability issue is the result of a design characteristic of a

SRAM (static random access memory) electronic component on the main printed circuit

board assembly. This particular component can be susceptible to moisture ingress resulting

in a potential malfunction. If this occurs, the Lifepak 500 device can fail to turn on. The

purpose of this correction is to notify customers who own Lifepak 500 aeds of this potential

issue and provide guidance for device storage practices that may exacerbate the issue.

A) VITEK 2 System - VITEK 2 Instrument

B) VITEK 2 System - VITEK 2 XL Instrument

bioMérieux Inc. 2011-08-22 2011-06-07 65099 Type II A) 27225

B) 27227

A) VTK23119 to VTK23754

B) VTK2XL2129 to VTK2XL3264

During the card loading process, the sealer card pusher assembly could inadvertently make

contact and move a cassette up to three card slots when the vacuum chamber is lowered,

which then causes the cassette to be out of alignment with the carousel incubator. As a

result of this misalignment, cards may be loaded into the carousel incubator in the wrong

order resulting in mismatched results, incorrect results or delay in treatment due to the need

to set up new cards.

D-10 Dual Program Reorder Pack Bio-Rad Laboratories Diagnostics Group 2011-08-22 2011-07-15 65741 Type II 2200201 20010663, 20010665 Certain lots of the elution buffer has engendered calibration failures and late retention times.

Ortho Provue Analyzer Micro Typing Systems Inc 2011-08-22 2011-07-21 65840 Type III MTS213784 >10 lot numbers Contact Manufacturers Ortho clinical diagnostics received a customer complaint regarding a misread of a sample

identification (ID) number when using the external hand-held Heron Datalogic D-130

barcode scanner with the Ortho Provue Analyzer. Under certain conditions the barcode id

displayed on the Ortho Provue Analyzer screen may not match the barcode on the sample

tube (i.e., the expected 6-digit barcode may be converted into a 9-digit barcode).

Defibtech Lifeline DDU-100 Semi-Automatic External

Defibrillator

Defibtech LLC 2011-08-22 2011-03-11 62337 Type I DDU-100A, DDU-100E N/A Software versions 2.004 and earlier for the DDU-100 series AEDs ("Lifeline") may be

affected by 1 or 2 conditions which in rare cases may cause an affected AED to cancel

shock during the charging process and not deliver therapy.

A) H.Lee SafeSheath Subclavian Introducer

B) H.Lee SafeSheath Sealing Adaptor

C) Transvascular Insertion Tool

Thomas Medical Products, a GE Healthcare Company 2011-08-22 2010-12-20 60649 Type II A) HLS-1006, HLS-1007, HLS-1009, HLS-1009.5, HLS-2507, HLS-2509, M209535-

008, M209535-013, M209535-015

B) MA02158A-008, MA02158A-012, SSSA-09, SSSA-EW-09

C) M930066A-001, TVI-07

A) S32159, S32993, S33083, S33308, S33309,

S32931, S32924

B) S33079, S32071, S32205, S32359, S33344,

S33486, S33752, S33346, S33485, S33753,

S32778+H16

C) S33557, S32830, S33028, S33628, S32606,

S33388, S33938

Thomas Medical Products has become aware that in some instances the pouch seal that

maintains the sterility of the product may be weak or open and compromise the sterile

barrier.

Dicom Q/R version 1.1.4 software Medtronic Navigation Inc. 2011-08-22 2011-06-01 64368 Type II version 1.1.4 N/A Medtronic Navigation is implementing a voluntary field correction of Dicom Q/R version

1.1.4 that is used to transfer patient exams from a PACS system to the Stealthstation. All

systems installed with Dicom Q/R version 1.1.4 will be upgraded to version 1.1.5.

A) Advia Chemistry System-Hemoglobin A1C (A1C) Assay

B) Advia Chemistry System-Hemoglobin A1C (HBA1C) Assay

Siemens Healthcare Diagnostics Inc. 2011-08-22 2011-06-28 65465 Type III A) 06854752

B) 06628018

A) LOT V41716

B) LOT V43263

Some kits of the Advia Chemistry HBa1c Calibrator Lot V43263 may have mislabelled vials

of level 5 and 6 calibrator. Also, Advia Chemistry A1C Calibrator Lot V41716 may have

mislabelled vials of level 1 and 2 calibrator.

A) Victory 10, 3 Wheel (SC610)

B) Victory 10, 4 Wheel (SC710)

Pride Mobility Products Corp 2011-08--22 2011-07-12 65743 Type II A) SC610

B) SC710

A) >100, Contact manufacturer

B) >1000, Contact manufacturer

Upon close examination of the Victory 10, it was determined that a batch of fuses were not

manufactured up to specifications. This could potentially lead to a unit failure or a fire due to

a fuse malfunction.

Stockert EP Shuttle System Stockert GMBH 2011-08-22 2011-07-19 65913 Type III 39D76X >10 lot numbers Contact Manufacturers Biosense Webster Inc. (A Johnson & Johnson Company) recently became aware that the

Stockert EP Shuttle System release notes describing software anomalies for Versions 1.035

and 1.037 were not previously communicated or provided to all customers. The field

notification is being issued to all customers to provide them with release notes.

A) Discovery MR750

B) Discovery MR450

C) Optima 450 WD

D) Optima 450 WE

GE Medical Systems LLC 2011-08-22 2011-07-05 65949 Type II A) M7000BH

B) DISCOVERY MR450 1.5T MR S

C) M7000WD

D) M7000WE

A) N/A

B) N/A

C) N/A

D) N/A

1) Inline post-processed (i.e. automated postprocessing) image locations are not correctly

annotated under some conditions. 2) Reference images displayed in Functool Fibertrak do

not match with the orientation annotations under some conditions.

Optima MR360 1.5T GE Hangwei Medical Systems Co. Ltd. 2011-08-22 2011-07-27 65950 Type II 5312366 (M50002BB) N/A 1) Inline post-processed (i.e. automated postprocessing) image locations are not correctly

annotated under some conditions. 2) Reference images displayed in Functool Fibertrak do

not match with the orientation annotations under some conditions.

Thermo Scientific Rotary Microtome HM355S-3 Thermo Anatomical Pathology Microm 2011-08-22 2011-07-07 65959 Type II HM355S 44828, 44829, 45411, 45429, 45430, 45708,

46101, 46269, 46277, 46324, 46325, 46326,

46974, 46975, 46976

Microm has identified a need to enhance the safety instructions and the description of the

devices in the safety manual regarding safe work practices as well as the addition of a new

quick-reference-card.

G7 Automtated Glycohemoglobin System - F & A2 Calibrators TOSOH Corporation 2011-08-22 2011-07-25 65968 Type III 20019 BCAL05R Calibrator solutions F & A2 give lower than expected values for calibration.

Howmedica Modular Resection System - Proximal Tibia Howmedica Osteonics Corporation 2011-08-22 2011-07-06 65586 Type II N/A >10 lot numbers Contact Manufacturers Stryker Orthopedics has initiated a product recall for the Howmedica Modular Resection

System - Proximal Tibia. This is in regards to a non-conformance: Due to the presence of

excessive material at the base of the slot feature in the distal femoral component as

observed on the returned per device.

Tendon Stripper Smith & Nephew, Inc., Endoscopy Division 2011-08-22 2011-07-19 65769 Type II N/A >10 lot numbers Contact Manufacturers It has been identified that the shaft tip material (casting) does not meet the Smith &

Nephew, Endoscopy Division 416 material specification, and therefore results in the rusting

of the distal end of the tendon stripper.

Atlantis Cervical Plate System Self-Tapping Screw Module

("Screw Caddy")

Medtronic Sofamor Danek USA, Inc. 2011-08-22 2011-07-19 65942 Type II 176-513, 976-516 All Lots It was discovered that the screw gauge located in the lower left corner of the screw caddy

used with the Atlantis Spinal System may not meet print specifications. It has been

observed that in some cases, the lines on the gauge were not placed on the caddy

according to specification, which could cause a screw to be measured improperly. An

incorrect gauge has been shown to measure a screw to be approximately 1mm shorter than

the actual screw length. This recall does not affect the new Atlantis Screw Caddy released

when the Universal instruments were launched in 2010.

Advantage Workstation with FuncTool version 6.3xx-9.3xx GE Medical Systems LLC 2011-08-22 2011-08-23 65987 Type II 5126889-X N/A GE Healthcare has become aware that image orientation of reference series displayed in

FuncTool Diffusion Tensor/Fibertrak Protocol on Advantage Workstation MRI applications

may not match with the orientation annotations displayed in the viewport. This issue may

impact patient safety.

Direct Drive Grasper Applied Medical Resources Corporation 2011-08-22 2011-06-24 65944 Type II C4130 1126120, 1137511, 1127581 Possible discrepancies in the in the material drying time and consequent injection molding.

Parameters during the manufacture of the respective locking trigger lots. As a result of

these non-conformities, there is potential.for the locking trigger to fracture during usage and

allow the grasper to remain in a closed position. All units/kits that were built with the suspect

lots of triggers have either been put in quarantine or are included in the recall.

PSM Software Roche Diagnostics Ltd 2011-08-22 2011-07-18 65956 Type I 4944607001 All serial numbers When used with QC and Validations modules, the PSM version 2.02.02b and 0.02.02c can

release patient results when they should actually be blocked for release by a QC Result

Failure.

PSM Software Roche Diagnostics Ltd 2011-08-22 2011-07-18 65957 Type I 4944607001 All serial numbers When using car rules, there is a possibility of the result being released to the LIS

(Laboratory Information System) prior to performance of the action dictated by the CAR

rule. This could result in unintended premature release of results, or release of results prior

to the addition of critical information such as flags or comments.

A) MagNA Pure LC 2.0 Instrument - Software version 1.1.23

and 1.1.24

B) MagNA Pure LC 1.0 Instrument - Software version 3.0.11


B) 12236931001

A) Software version v1.1.23, Software version

v1.1.24

B) Software version 3.0.11

Software malfunction causing liquid handling problems observed with Magna Pure LC 1.0

Instrument (Software version 3.0.11) and Magna Pure LC 2.0 Instrument (Software versions

1.1.23 and 1.1.24).

CK-3 Large Full Radius Scalpel Ormco Corporation also trading as Sybronendo 2011-08-22 2011-05-18 63869 Type III 975-0011 100813 One lot of scalpel packages labeled as CK-3 Large Full Radius Scalpel, Part# 975-0011,

actually contained CK-6 Small Full Radius Scalpel. The package listed the correct part

number, but included the incorrect part.

Omnidiagnost Eleva Philips Medical Systems Nederland B.V. 2011-08-22 2011-06-12 65597 Type III 708027 N/A Due to a software anomaly, the camera may intermittently shut off causing a loss of

fluoroscopy, resulting in an interruption of the examination.

Plastic Needle with Mandrin Varian Medical Systems, Inc. 2011-08-22 2011-07-13 66002 Type II GM11007560, GM11007570, GM11007580 >10 lot numbers Contact Manufacturers Previous Recall (53838) addressed needle tip may separate from the needle shaft such that

the tip may detach in the patient upon withdrawal. Recall 66002 supplements and modifies

previous notice,where users are instructed to stop using any plastic needles they may have

in inventory with Lot numbers C01 to D01 and those with Lot numbers which start with H or

I. This recall also requires users to return any plastic needles with Lot numbers C01 to D01

and those Lot numbers which start with H or I to Varian Brachiotherapy for replacement with

plastic needles starting with lot J or higher.

Neptune 2 Waste Management System - Rover Stryker Instruments 2011-09-05 2011-07-25 65943 Type III 0702-001-000 733700353 Stryker Instruments has received reports of casters failing in the field. The caster failures

have resulted from the "swivel head of the caster which is a double ball bearing composed

of polyamide that loosens over time" creating excessive swivel play. The resultant swivel

play allows the caster to bind/jam with the chassis of the rover when force is applied by the

operator to move the device.

Synchron LX Systems Apoa Reagent Beckman Coulter Inc. 2011-09-05 2011-08-01 66071 Type III 467900, 469170 M101837, M009389 Beckman Coulter Inc. identified lot-to-lot shifts in patient results when switching lots of Apoa

Reagent or Apo Calibrator.

Coulter DXH Cell Lyse Beckman Coulter Inc. 2011-09-05 2011-08-01 66072 Type III 629029 0710001, 0710002, 0710003, 0710004,

0711001, 0711002, 0711003, 0712001, 0712002

Beckman Coulter Inc. identified elevated background counts in the Coulter DxH Cell Lyse.

As a result of the elevated background counts, the Bodyfluids Control Level 1 is not

recovering within range.

TempSpan CMT Kerr Corporation, also trading as Pentron Clinical 2011-09-05 2011-05-18 66108 Type III N69CA 3748413 Received complaints of dark stain under product when temporary crown was removed and

that product did not set.

A) 37% Phosphoric Acid Etching Gel

B) Etch Gel

C) Cement-It - Cementation System Kit

D) Mojo Veneer Cement

Kerr Corporation, also trading as Pentron Clinical 2011-09-05 2011-05-17 64744 Type III A) N10

B) N01H, N01IB, T06, T06A, T06B

C) N33

D) N06K

A) All made since Apr 2007 with expiry btwn

2011/04-2015/04

B) All made since Apr 2007 with expiry btwn

2011/04-2015/04

C) All made since Apr 2007 with expiry btwn

2011/04-2015/04

D) All made since Apr 2007 with expiry btwn

2011/04-2015/04

It was discovered that the product continues to extrude out of the syringe even after

pressure is no longer applied. The affected products actually contain 45% phosphoric acid

rather than the correct 37%.

Triage Drugs of Abuse Plus TCA Test Kit Alere San Diego, Inc. 2011-09-05 2011-07-01 65583 Type III 168406 238928, 235991 There has been an increase in the number of unexpected positive thc results.

30" Transport Stretcher Stryker Medical 2011-09-05 2011-07-28 65795 Type III 0748-000-000 1102034555 to 1102034560 Stryker Medical has determined that the brake rod assemblies of the above referenced

stretcher models that are built with a "5th wheel" series stretcher base were manufactured

with roll pins that did not meet the material specifications. Accordingly, some roll pins may

have fractured during the assembly process and could fall out of the brake rod assemblies,

rendering the brake or steer systems inoperable from certain pedals or causing a reduction

in overall brake holding force.

A) VITEK 2 Compact 30 System

B) VITEK 2 Compact 60 System

C) VITEK 2 System

D) VITEK 2 XL System

bioMérieux Inc. 2011-09-05 2011-07-25 65958 Type III A) 27530

B) 27560

C) 27225

D) 27227

A) N/A

B) N/A

C) N/A

D) N/A

The Vitek 2 Systems bioArt rules that enforce the limitations of Cronobacter Sakazakii (c.

Sakazakii) are not included in the pre-defined bioart limitation rules released in the version

5.01 software. Enterobacter Sakazakii was moved out of the Enterobacter species group

and renamed to c. Sakazakii group. These pre-defined bioArt rules were not updated to

include c. Sakazakii group, therefore the rules are not appropriately applied when the

organism identification is c. Sakazakii group.

A) Access Immunoassay Systems Total T4 Calibrators

B) Unicel DXI 600 Access Immunoassay System - Total T4

Assay

C) Unicel DXI 800 Access Immunoassay System - Total T4

Assay

Beckman Coulter Inc. 2011-09-05 2011-07-25 65988 Type III A) 33800, 33805

B) 33800, 33805

C) 33800, 33805

A) Total T4 Calibrators 021654

B) Total T4 Calibrators 021654

C) Total T4 Calibrators 021654

Beckman Coulter Inc., identified access total T4 calibrator Lot 021654 do not meet their 12

month expiration date claim. Patient and quality control results may be falsely decreased by

2 standard deviations or more. This decrease may be seen as early as ten months prior to

the labeled calibrator expiration date.

Breeze Self-Adhesive Resin Cement Pentron Clinical Technologies, LLC 2011-09-05 2011-07-21 66129 Type II N97A 3558203, 3581367, 3564511, 3538478 Possible curing problem with cause cemented crowns to fall off after use of product.

Wick Lip Bumper Ormco Corporation 2011-09-05 2011-07-29 66136 Type III 293-0162, 293-0163 041158162, 041158163 Complaint indicating the Wick Lip Bumpers had hooks that were welded reversed.

Mini Twin Brackets-left and right Ormco Corporation 2011-09-05 2011-07-29 66138 Type II 329-0350, 329-0351 031157404, 041173689, 3673684 Mini Twin Brackets were labeled as having no hooks actually contained Mini Twin Brackets

with hooks.

Spider 2 Limb Positioner Smith & Nephew, Inc., Endoscopy Division 2011-09-05 2011-07-28 66017 Type II 72203299 73, 79, 80, 99, 103, 104 It has been identified that the Spider 2 Limb Positioner may unlock (loss of traction)

resulting in the potential movement of the patient when the device is within close proximity

to an RF (radiofrequency) source. Loss of traction can potentially result in the unintended

repositioning of the extremity within traction. There is a potential for tissue or cartilage

damage to occur due to the unexpected and sudden repositioning.

Mizuho OSI Modular Table Systems Mizuho Orthopedic Systems, Inc. 2011-09-05 2011-08-04 66074 Type III 5803, 5855, 5927, 5943, 5943-AP, 5943APNC, JTS, MTS, OITSITS, OTS All Serial Numbers Field advisory notice intended to further educate all users on certain aspects of the device.

Aixplorer Ultrasound System - Main Unit Supersonic Imagine 2011-09-05 2011-08-04 66102 Type II SSIP90019 SIB5127, SIB5128, SIB5129, SID0918,

SID2531, SIC4724

A problem occurs within the Aixplorer V4.2 Software when using the TAMV (Time Average

Mean Velocity) tool in PW mode. When used under certain conditions, the calculation of

the mean velocity value, deduced from the peak value, could be erroneous. Therefore, the

TAMV calculation displayed on the monitor is incorrect.

A) ReNew Long Fenestrated Grasper

B) ReNew Super-Atrau Fenestrated Grasper

Microline Surgical, Inc. 2011-09-05 2011-07-18 66154 Type II A) 3262

B) 3642

A) 00105332

B) 00105709

The ReNew product number 3262 (Long Fenestrated Grasper) was packaged and labeled

as product number 3642 (Super-Atrau Fenestrated Grasper).also, the ReNew product

number 3642 (Super-Atrau Fenestrated Grasper) was packaged and labeled as 3262 (Long

Fenestrated Grasper).

OptiBond FL Kerr Corporation 2011-09-05 2011-07-07 66168 Type III 33352 >10 Lots, Contact Manufacturer One lot has not camphorquinone resulting is a clear, rather than yellow colour. Product will

perform as intended.

Marus LuxStar Dental Light Dental Equipment, LLC DBA. DCI Equipment 2011-09-05 2011-06-11 66172 Type III CB1000, CL1000, ML1000, OL1000, TL1000, UL1000, WL1000 All lots distributed between 2004/04-2010/12 When lens heat shield of dental light is not properly installed or maintained, it my fall and

burn/cut the patient in dental chair.

Direct Drive Disposable Laparoscopic Grasper Applied Medical Resources Corporation 2011-09-05 2011-06-22 66179 Type II C4130 1126120, 1137511, 1127581 Some non-conformances have been identified that have the potential for the locking trigger

to fracture during usage and allow the grasper to remain in a closed position.

Tomotherapy Treatment System-Kit Power Tomotherapy Incorporated 2011-09-05 2011-07-13 65771 Type II 101264 N/A During Dicom export of plan level images with a non square exported Field of View (FOV),

an anomoly in the process of squaring the plan level image may cause the image to shift

with respect to ROI's and dose. When the anomoly occurs, the magnitude of the image shift

can be a full IEC-X Voxel, a full IEC-Z Voxel, or full Voxels in both IEC-X and IEC-Z.

ON-Q Pumps with Select-A-Flow I-Flow Corporation 2011-09-05 2011-08-09 66207 Type III CB004, CB005, CB6007 032678, 992877, 9C2263, 9C2326 I-Flow Corporation determined that approximately 0.4% of On-Q Pumps with Select-A-Flow

may develop a minor leak. If a leak occurs, it may not be detected during filling or priming

of the pump.

Marus Luxstar Dental Light Dental Equipment, LLC DBA DCI Equipment 2011-09-05 2011-06-11 65582 Type III N/A ML1000, OL1000, CL1000, UL1000, TL1000 When lens heat shield of dental light is not properly installed or maintained, it may fall and

burn or cut the patient in dental chair.

A) Twist Drill Bit

B) Tip Threaded Guide Pin

C) Guide Pin Bayonet Point

D) Guide Pin Trocar Point

E) Peri-Loc Periarticular System - K-Wire with Trocar Point

F) Swanson Finger Wire

G) Cobalt Chrome Trochar Tip Wire

H) Cobalt Chrome Drill Tpe Threaded Wire

I) Cobalt Chrome Drill Tip Wire

J) Drill

Smith & Nephew Inc. 2011-09-05 2011-07-06 65948 Type II A) 71134064

B) 71123200

C) 128039

D) 128047

E) 71161012, 71161016, 71161020

F) 128145, 128147

G) 71101507, 71101509

H) 71101504, 71101505

I) 71101503

J) 71173801, 71173803, 71173805

A) 10EM07430

B) 10DM17100

C) 10EM11762, 10FM12052, 10FM11506



F) 10EM05885, 10EM05897, 10FM15942,

10GM01542

G) 10GM01572, 10GM01568

H) 10GM01559, 10EM11863

I) 10EM11858


The tubing packaging used to package these items appeared to be oversized and could

potentially allow the end caps to come loose, enabling the product to puncture the sterile

packaging.

Slidex Staph Plus bioMérieux Inc. 2011-09-05 2011-08-09 66152 Type III 73115, 73116 1011103570, 1011103604, 1007103265,

1007103205

Further to complaints, the manufacturer's investigation have detected a problem with

certains lots of R1 reagents specificity (Anti-Staphylococcus Aureus Latex) leading to false

positive results with Staphylococcus Non Aureus strains.

A) Senographe DS Full Mammography System

B) Senographe Essential Mamography System

GE Medical Systems SCS 2011-09-05 2011-08-02 65770 Type II A) S30321JR

B) 5144816, 5144816-1-1, 5144816-3, 5144816-4, 5144816-5, 5144816-6,

5144816-7, 5144816-8, 5144816-9, 5144816-9E

A) All

B) All

Measurements on magnification images at different workstations, e.g. Siemens or RA1000,

lead to different results. There is a Dicom Tag Image error.

SoftPath GUI versions 3.17.5 to 3.17.9, 4.2.1 to 4.2.3 and

4.3.0 to 4.3.0.4

SCC Soft Computer 2011-09-05 2011-07-13 66148 Type II SOFTPATH GUI VERSIONS 3.1>,SOFTPATH GUI VERSIONS 4.2>, SOFTPATH

GUI VERSIONS 4.3>

N/A For clients using AP Macros or Datafields inside Report Template Document Section that

save to the database, the data may not be correctly updated in the database.

FlexCath Steerable Sheath, Model 3FC12 Medtronic Cryocath LP 2011-09-05 2011-07-19 66159 Type II 3FC12 >10 Numbers, Contact Manufacturer This field notification is to inform affected customers of an observation related to a potential

leak in the hemostatic valve of the FlexCath 12 Steerable Sheath, Model 3FC12, and

provided information on the best approach to recognize and manage the observation.

In May 2011 the rate of occurrence of hemostatic valve leaking related issues rose from

0.35% to 2.47%. the reported failures are hemostatic valve leaking and air ingress during

aspiration.

Due to the design difference of the 12 French sheath from the 10 French sheath and the

increase in the rate of occurrence being specifically related to the 12 French model of the

FlexCath Sheath, the communication is being focused on the 12 French Sheath Model.

SoftPath GUI versions 4.2.3.3 to 4.2.3.6 and 4.3.0.5 to

4.3.0.12

SCC Soft Computer 2011-09-05 2011-07-20 66258 Type II SOFTPATH GUI VERSIONS 4.2>, SOFTPATH GUI VERSIONS 4.3> N/A For clients using a customized lab results ap macro or a micro results results ap macro in

the patient report template, there is a possibilility that the lab tests displayed may be only for

the first order from the date range for the patient.

NeuroTrac MyoPlus2 Verity Medical Ltd. 2011-09-05 2011-06-01 65964 Type III MY0220 2011 MYO220 001 An anomaly was found in the software in a limited number of MyoPlus 2 devices. In certain

circumstances (both stimulation channels turned up, the difference in intensity between the

channels is more than 5 MA), this anomaly can cause the muscle stimulation output of

channel 1 to stop increasing when the display on the lcd passes 45 MA. Even though

continued pressing of the channel 1 "MA+" control button increases the reading on the lcd

display up to the maximum of 90 MA the actual output stays at 45 MA. However, if and

when the intensity of channel 2 is increased, as you pass 47 ma, channel 1 immediately

corrects itself so that the output MA is the same as the lcd display for channel 1. The same

problem exists in channel 2 if channel 2 is the first to be turned up past 45 MA and then

channel 1 is increased above 47 MA. A potentially hazardous situation associated with the

use of the device is a sudden surge of stimulation on one of the output channels which

could be experienced by users as an unpleasant shock situation.

Center Drive Blade 2.0 Biomet Microfixation, Inc. 2011-09-05 2010-03-16 65974 Type III 01-9047 64980 Potential risk identified is that the blade will not engage or retain screws for specified lot.

A) 5 Panel Drugcheck NxStep Cups

B) 10 Panel Drugcheck NxStep Cups

C) Drugcheck NxStep Cups with Alcohol

D) Drugcheck 2 Panel Dips

E) 6 Panel Drugcheck NxScan Cups

Express Diagnostics International Inc. 2011-09-05 2011-04-28 65559 Type III A) 60505

B) 61020

C) 60500 A

D) 30200

E) 70610

A) 505031911, 505032311, 505022511

B) 020021411

C) A500 022111, A500040711

D) 200012411, 200020311

E) 610042111

Distributed product into Canada without license.

Lightspeed VCT CT Scanner System GE Medical Systems, LLC 2011-09-05 2011-08-10 65945 Type III 5212920-3XX All The ECG waveform trace may be missing in retro recon from scan data where the R-peak

coincides with X-ray on signal resulting in captured data for an extra R-peak. As a result, the

ECG waveform trace will not display and retrospective reconstruction is not possible for that

series.

A) Allura XPER FD10/10-Main Unit

B) Allura XPER FD20/10-Main Unit

C) Allura XPER FD10

D) Allura XPER FD20 System Main Unit

Philips Medical Systems Nederland B.V. 2011-09-05 2011-08-02 65985 Type II A) ALLURA XPER FD10/10

B) ALLURA XPER FD20/10

C) ALLURA XPER FD10

D) ALLURA XPER FD20

N/A Philips has identified a problem related to the hard disk firmware in allura XPER systems.

The hard disk itself is working firmware has an incorrect incrementing smart counter. This

might result in a very high "raw read error" count which will lead to a so called "smart trip"

and subsequently will take the hard disk offline. Consequently the system might

intermittently freeze. This can vary from several seconds up to one minute.

A) Drugcheck Dip Drug Tests

B) AlcoCheck Breath Alcohol Screening

C) Alcocheck Saliva Alcohol Screening

D) DrugCheck Urine Alcohol Screening

E) DrugCheck NxStep 14 Panel Cups

F) Diagnostics Oraline Swab 4 Panel Drug Test

G) QED Alcohol Saliva Test

H) Drug Adulteration Test Strip

Express Diagnostics International, Inc. 2011-09-05 2011-04-28 65563 Type III A) 30100, 30110, 30111C, 30120, 30130, 30130C, 30140, 30140C, 30150, 30160,

30163, 30170, 31005

B) 40902, 40908

C) 40900

D) 40901, 40901C

E) 61401

F) 40940

G) N/A

H) D700-25

A) All

B) All

C) All

D) All

E) All

F) All

G) All

H) All

Distributed product into Canada without license. Products distributed not listed on the Class

2 license.

A) Sensura Post-Op Sterile Ostomy Bag

B) Sensura 1 pc. Drainable Sterile Ostomy Bag

C) Assura/Alterna Post-Op Sterile Ostomy Bag

Coloplast A/S 2011-09-05 2011-07-25 66065 Type II A) 19010, 19011

B) 19001

C) 12808, 12810

A) 2785856, 2932899, 2785854

B) 2744872

C) 10#S - Contact Coloplast

Failure of sterility testing. Sterility may be compromised in these products.

Soothing Heat Cold Pack Warm Buddy Comp 2011-09-05 2011-07-15 66141 Type III 1200,1200B, 1200C, 5009A, 6001, 6005, 6006, 6008, 6012, 8009, 8012, 8012B,

8013, 8015, 8018, 8019, 8020, 8028, 8028B, 8028C, 8029, 8030, 8030B, 8030C,

8031, 8032, 8035, 8035P, 8040

N/A The reason of the recall is for the exchange of the outer labels with the Medical Devices

Bureau (MDB) approved labels along with the stick on label for the double sewn seam on

the inner pack of each plush animal.

Uni-Solve Adhesive Remover Wipe Medtronic MiniMed 2011-09-05 2011-07-28 66310 Type II MMT-643 9K155 Potential bacterial contamination of certain lots of Uni-Solve Adhesive Remover Wipes

manufactured by the Triad Group for Smith & Nephew and Co.-packaged in the Medtronic

Site Adhesive sample kit.

Coseal Surgical Sealant Baxter Healthcare SA 2011-09-05 2011-07-28 66014 Type III 934071 HA090944, HA090950 The recall is being conducted as a precautionary measure due to Out of Specification

(OOS) results observed at the 24 month time point (out of 24-month licensed shelf life to

expiration) during a Coseal Stability study. The parameter that is OOS is an indicator of

possible failure for the product to gel appropriately. All other stability requirements were met.

Dimension Vista Cuvettes Siemens Healthcare Diagnostics Inc. 2011-09-19 2011-08-09 66119 Type III KS850 N/A There is a low frequency defect in the molding of the cuvettes that may result in cuvette ring

and cuvette loader jams. Jams will cause downtime on the system. The molding defect can

result in the cuvette flange or "wing" breaking, resulting in an error condition. No results are

reported when jams occur, therefore patient results are not impacted.

AlloFit MIS Setting Device for Pole Plug Zimmer GMBH 2011-09-19 2011-08-12 66239 Type III 01.00502.007 10524172 The intended use of the instrument is to bring the pole plug for Allofit / Allofit it hip cups in

the correct position in order to fix the pole plug in the implant shell. In Lot 10524172 a

discrepancy was found. The spring and washer to keep the pole plug in place are missing on

the devices of this lot.

Endopath ETS Compact Flex 45 Cutter Ethicon Endo-Surgery, LLC 2011-09-19 2011-08-22 66387 Type II CTS45 >100 Numbers, Contact Manufacturer Ethicon Endo-Surgery has initiated a global recall for specific production lots of Endopath

ETS Compact Flex 45mm Articulating Linear Cutters because the possibility exists that

damage to the blister pack may compromise the sterility of the device.

Horizon Medical Imaging (HMI) McKesson Medical Imaging Company 2011-09-19 2011-06-13 64937 Type II N/A 11.5, 11.5.1, 11.5.2, 11.6, 11.7, 11.8 McKesson received a report from one of their customers where images for one patient

appeared in the study of another patient in their Horizon Medical Imaging (HMI) system.

The incorrectly displayed study showed the images for patient a, but with name, Medical

Record Number (MRN), procedure type and other database overlay information for patient

B.

IUD Insertion Kit Gyn Disposables, Inc. 2011-09-19 2011-07-29 66030 Type III 935K 61034034 Potential for IUD Insertion kit pouches not being sealed adequately.

A) Spacelabs Medical Patient Monitor 91370

B) Spacelabs Medical Patient Monitor 91359

C) Spacelabs Medical Patient Monitor 91387

Spacelabs Medical, Inc. 2011-09-19 2011-08-07 66067 Type II A) 91370

B) 91369

C) 91387




Spacelabs Healthcare has identified an issue with model 91367, 91369, 91370, 91387 &

91393 medical patient monitors equipped with the perioperative option (-D). One customer

reported a safety concern over the inability to recognize the status of the monitor's audible

alarms when the device has been left in the end case mode.

Fluoroscan Mini C-Arm Office Mate Hologic, Inc. 2011-09-19 2011-08-22 66535 Type II 50600 S/N: 02-0204-01, S/N: 02-0304-01, S/N: 02-

0903-01, S/N: 02-0899-13

Fluorscan Mini C-Arm Models Office Mate which could experience the following failure: The

Flex Arm Connector to C-Arm can break and the C-Arm that is supported by the Flex Arm

will fall down. Review of the design determined that the casting wall where a threaded hole

is located for a set screw is marginal and there is a possibility that should there be an impact

to that area, the wall could break causing the C-Arm to fall down.

A) TiLite ZR Series 2 Wheelchair

B) TiLite ZRA Series 2 Wheelchair

Tisport, LLC. 2011-09-19 2011-07-28 66405 Type III A) Z2FS2

B) Z2FS1



Two of the bolts that comprise part of the backrest hinge assembly-namely pivot stud and

lock stud-may fail.

Syngo Imaging XS VA70A Siemens AG 2011-09-19 2011-08-03 66198 Type II 10496279 N/A The "rename" functionality can cause an unintended patient merge if the renamed patient is

sent to another system. If a patient study is renamed on one syngo imaging XS system and

sent to another Syngo Imaging XS System, then the entire patient is renamed on the second

system.

Etac Premium Handling Belt Etac AB 2011-09-19 2011-08-18 66367 Type II 255303-Premium Handling Belt,

255304-Premium Handling Belt,

255305-Premium Handling Belt

N/A This is a field corrective action on Premium Handling Belts produced before 2011. The

issue is that the male part of the buckle can detach during transport or washing. Also,

washing temperatures on the label were lower than temperatures recommended by the

authorities.

A) Transactive Lifts (TA)

B) Transportable Lifts (TP)

Waverley Glen Systems - Division of Prism Medical Ltd. 2011-09-19 2011-08-16 66368 Type II A) 313100-TA Manual Traverse, 313150-TA Power Traverse, 313175-TA Power

Traverse, 313177-TA Power Transtrip

B) 303000-Transportable Lift, 303030- Transpoint TP Lift

A) S/N: TA200000 - TA600279

B) S/N: TP10000 - TP106460

There was a notice from Prism Medical indicating a revised guidance on inspection and

replacement for lift straps on TA and TP lifts. Per the notice received, during an inspection

of a lifting tape on a lift that was being used in excess of 14 times a day at its full extent,

excessive wear was noticed on the lift strap where the lift strap entered the tape gear. This

part of the lift strap is not visible without lift strap removal. The lift strap in the ceiling lift was

approximately 3 years old.

A) Duet TRS Universal Straight Sulu

B) Duet TRS Articulating Sulu

Covidien LLC 2011-09-19 2011-08-18 66450 Type II A) Duet4535, Duet4548, Duet6035, Duet6048

B) Duet4535A, Duet4548A, Duet6035A, Duet6048A

A) >10, Please Contact Manufacturer

B) >10, Please Contact Manufacturer

There is a potential for the sterility and moisture barrier to be compromised.the use of the

products with this condition may result in a potentially increased risk for infection and/or

degradation of the reinforcement material.

Centrifuge Tube Racks for Prestain TriPath Imaging, Inc. 2011-09-19 2011-05-27 65792 Type III 799-13001-02 236 The PrepStain instrument automatically prepares and stains slides for cytology. Stains and

rinses are applied to the sample in order to prepare the slide for cover slipping. A centrifuge

is used as part of the sample preparation process. The centrifuge tube rack #2 is keyed

incorrectly, not allowing proper alignment of the tube holders with the prepstain waste

station. This could result in potential delays in processing of slides and thus create potential

delays in reporting of patient results.

BrainLAB Skull Reference Base BrainLAB AG 2011-09-19 2011-08-08 65973 Type II 52120D, 52121B, 52129, 52129A N/A Applying too much or tensile force to the head of the screw during insertion and fixation of

the skull reference base may cause the screw head to deform or to shear off. In such case,

the screw can no longer be removed the specified screwdriver or parts of the screw may

remain inside the patient's skull bone.

GemStar Docking Station Hospira Inc. 2011-09-19 2011-08-01 66150 Type II 13075 >10, Please Contact Manufacturer Hospira Inc. received customer's report of sparking, smoking, charring and shock when

using the GemStar Docking Station. Hospira is recommending that all fluid ingress into the

device is avoided.

Syngo Plaza Siemens AG 2011-09-19 2011-08-08 66199 Type II IVK 105 92 457 S/N 100011 If a patient study is renamed on one Syngo.Plaza or Syngo Imaging XS System and sent to

another Syngo.Plaza or Syngo Imaging XS System, then the entire patient is renamed on

the second system. This can cause an unintended merge of patients.

Electa Synergy XVI (X-ray Volume Imaging System Elekta Limited 2011-09-19 2011-03-09 66455 Type II N/A Version 4.5.0 Incorrect Monitor Units (MU) are recorded after "confirm settings" or "unconfirm settings" is

pressed.

Lina Loop Lina Medical APS 2011-09-19 2011-01-01 66458 Type II EL-160-8, EL-200-4, EL-200-8 7282, 7415, 8283, 8284, 8285, 8292, 8393,

8395, 8411, 8442, 8453, 9081, 9131, 9231

There is a potential for the device Lina Loop to break during the operating procedure.

Syngo Dynamics Siemens Medical Solutions USA, Inc. 2011-09-19 2011-08-25 66598 Type II 10090480 S/N 92241 This advisory is specific to customers who have upgraded to Syngo Dynamics Version 9.0

with Legacy reports generated by Syngo Dynamics Systems Version 3.x or earlier. If a

Legacy report is opened in Syngo Dynamics 9.0 Web Portal, the report may be deleted and

replaced with a new report from the 9.0 reporting system or with a blank report.

Syngo Imaging SX Siemens AG 2011-09-19 2011-08-26 66599 Type II 10496279 S/N 1225, S/N 2006, S/N 2163 Customer safety advisory notice to inform customer of an unitended behavior when using

Syngo Imaging XS, Versions VA70A and VA70B client/server installations. Loading images /

series from patient browser using the thumbnails can cause an unintended deletion of

images / series.

Dimension EXL System - (Troponin) TNI Assay Siemens Healthcare Diagnostics Inc. 2011-09-19 2011-08-31 66699 Type III RC621 1AD045 There have been customer inquiries for discordant results on QC and patients following

calibration with Lot LAD045. Internal testing has confirmed a 30% positive shift between the

99th percentile (0.056 ng/ml) and 0.1 ng/ml. Operations has confirmed the accuracy of

subsequent Lots of calibrator.

A) Cell-Dyn 3500 Haematology System - CS Analyzer

B) Cell-Dyn 3500 Haematology System - Refurbished CS

Analyzer

C) Cell-Dyn 3500 Haematology System - Sl Analyzer

D) Cell-Dyn 3500 Haematology System - Refurbished Sl

Analyzer

Abbott Laboratories Diagnostic Division 2011-09-19 2011-10-22 56461 Type III A) 91340-01

B) 91340-03

C) 91350-01

D) 91350-03

A) All

B) All

C) All

D) All

Cell-Dyn 3700 customers had reported occurrences of visible fire and smoke from the

analyzer. In addition, a Cell-Dyn 3200 customer reported smoke from the analyzer.

Returned power supply units were analyzed and were identified to contain the incorrect fuse

for the electrical configuration at the customer site.

A) Cell-Dyn 3700 Haematology System -Sl Analyser

B) Cell-Dyn Ruby Haematology System - Analyzer

C) Cell-Dyn 3500 Haematology System

Abbott Laboratories Diagnostic Division 2011-09-19 201103-24 62481 Type III A) 02H31-01

B) 08H67-01

C) 91350-03

A) 20576AK

B) 35705BG

C) 32159P96

The shear valve assembly was rejected during testing in manufacturing due to a "shear

valve position" fault or "RBC diluent syringe overpressure" sim. It was noticed that the nylon

washer (pn 2808159) had an outer diameter which was OOS (undersized) causing it to

become caught within the adjacent drive plate's opening.

A) Instatrak 3000 - Sensor Cables

B) Instatrak 3500 - Sensor Cables

C) Instatrak 3500 Plus - Sensor Cables

GE OEC Medical Systems Inc. 2011-10-03 2011-04-05 62579 Type III A) 1001989, 1002008

B) 1001989, 1001990, 1002008, 1004069

C) 1007907-NAV, 1007914-NAV

A) All

B) All

C) All

The customer labelling for transmitter sensor cables and receiver sensor cables states that

the cables can be sterilized with the Sterrad Sterilization System. At the initial release of

these products, the only sterrad method was the 100S model. Sterrad has since introduced

the 100NX and NX models. The transmitter sensor cable and receiver sensor cable have

been validated for sterilization in the sterrad 100S Sterilizer and Ethylene Oxide (ETO)

Sterilizers only. These products have not been validated for use in any other Sterrad

Sterilizer. GE OEC Medical Systems Inc. internal testing has shown the high concentration

of hydrogen peroxide used in the Sterrad 100NX Sterilizer is not compatible with some of

the materials used in the transmitter sensor cable, which may result in the degradation of

the material. This could lead to a sterilization issue. Testing shows that the receivers are not

affected by the change in sterilization.

Warmair Model 134 Cincinnati Sub-Zero Products 2011-10-03 2011-06-09 65793 Type II 134 963-1340100 to 004-1341426 One of the connectors attached to the Warmair 134 device's printed circuit board can

overheat. May result in damage to the device's external case and/or melting of some of the

internal components.

Segmented Cylinder Set Varian Medical Systems Inc. 2011-10-03 2011-07-13 66153 Type II GM11004150 > 10 Serial Numbers Contact Manufacturer In the previous recall (55250), the blocking washer on the flexible probe (GM11002420) may

shift and users are not to use a flexible probe with an unstable or shifted blocking washer

due to potential for treatment error. This update notice supplements and modifies the

previous instructions that you may continue to use the original design flexible probe with

blocking washer and old design guiding tube. Here, users are instructed to stop using these

older products (GM11002420) flexible applicabtor probe with blocking washer at 234 mm

(Old design) GM11005170 guiding tube for segmented cylinders (Old design). This update

notice request requires that users return these original design products to varian

brachytherapy for replacement with the updated designs for them free of charge.

A) Omnifuse Syringe Pumps

B) Omnifuse PCA Syringe Pump

Smiths Medical ASD. Inc. 2011-10-03 2011-08-03 66188 Type II A) 0158-0710, 0159-0710

B) 0153-0710, 0153-0711

A) All

B) All

1) Possible impact of significant vibration or jarring to Omnifuse pumps: Due to sensitivities

of the precision accuracy detection mechanisms within Omnifuse pumps, certain levels of

vibration or jarring during transport can induce a system fault code.

2) Affect on the Totaliser display after resetting the pump to clear a system fault: If a system

fault code occurs during an infusion and the pump is reset, the Totaliser display will not

include the most recent infusion data.

A) Reagent Red Blood Cells SELECTOGEN

B) Reagent Red Blood Cells AFFIRMAGEN

C) Reagent Red Blood Cells SURGISCREEN

D) ORTHO Confidence System

E) Blood Grouping Reagent Anti-D (Murine Monoclonal Blend)

BioClone for Slide

F) Reagent Red Blood Cells 0.8% SELECTOGEN

G) Reagent Red Blood Cells 0.8% SURGISCREEN

H) Blood Grouping Reagent Anti-A (Murine Monoclonal Blend)

BioClone for Slide

I) Blood Grouping Reagent Anti-B (Murine Monoclonal Blend)

BioClone for Slide

J) Blood Grouping Reagent Anti-A,B (Murine Monoclonal

Blend) BioClone for Slide

K) Reagent Red Blood Cells 0.8% AFFIRMAGEN

Ortho-Clinical Diagnostics Inc. 2011-10-03 2011-08-19 66317 Type III A) 79610

B) 719210

C) 719100

D) 6902096

E) 6901939

F) 6902315

G) 6902316

H) 711228

I) 711328

J) 711528

K) 71901

A) S531

B) A282

C) 3SS407, 3SS408

D) CNF790, CNF786

E) DB285A1, DB286A1, DB287A

F) VS466

G) VSS399

H) BAA587AX, BAA588AX, BAA589AX

I) BBB778AX, BBB779AX, BBB780AX,

BBB781AX

J) ABB692AX, ABB693AX

K) 8A694, 8A704

Ortho Clinical Diagnostics has received complaints of broken vials during shipment for

some Ortho blood products. Studies show that vial to vial contact during the shipping

process is one of the key contributors to this vial breakage. / Ortho-Clinical Diagnostics a

reçu une plainte selon laquelle des fioles ont été cassées pendant le transport de certains

produits à base de sang. Des études montrent que le problème résulte principalement d’un

choc entre des fioles durant la livraison des produits.

28 mm & 30 mm AcuTwist Acutrak Compression Screws Acumed Inc. 2011-10-03 2011-08-03 66546 Type III N/A AI-0028-S, Lot 248000, AI-0030-S, Lot 250212 Product is labeled as AI-0030-S, Batch 25012 but an AI-0028-S, Batch 248000 is inside the

packaging. Product is labeled as AI-0028-S, Batch 248000 but an AI-0030-S, batch 250212

is inside the packaging. Based on Acumed's health hazard evaluation, there is no additional

risk to health to the end user of this product. Acumed received a customer complaint on

7/22/2011.

A) ViziShot Single Use Aspiration Needles

B) ViziShot Single Use Aspiration Needles

Olympus Medical Sysrtems Corp. 2011-10-03 2011-09-06 66569 Type III A) NA-201SX-4022

B) NA-201SX-4021

A) All

B) All

Olympus is aware of complaints in which users are able to wipe metal particles from the

stylet of the ViziShot's needle. The metal particles may contaminate the specimens

obtained during fine needle aspiration.

BD Retic-COUNT Reticulocyte Reagent System Becton, Dickinson and Company BD Biosciences 2011-10-03 2011-08-15 66631 Type III 349204 3847 Storage condition printed on shipping container state 2-25 C and should state 2-8 C. the

storage condition printed on the bottled product is correct (2-8 C).

A) Sta-System Control N+P

B) Sta-System Control N+P

Diagnostica Stago SAS 2011-10-03 2011-08-18 66632 Type III A) 00678

B) 00678

A) 106775

B) 106775

Diagnostica Stago was aware that STA System Control N+P Factor VIII results were not

within the assigned acceptance range.

Architect System - Alkaline Phosphatase Assay Abbott Laboratories Diagnostic Division 2010-10-03 2011-08-30 66698 Type III 7D55-21, 7D55-31 62474UN10, 71628UN10, 08145UN11 Alkaline phosphatase has been reported to contain visible mold inside multiple R2

cartridges. In-house visible observation of customer returns and in-house R2 reagents found

visible matter inside multiple R2 cartridges. In-house testing was performed, the lot failed to

calibrate/generate results and failed to meet the following specifications: microbial

contamination of less than 30 CFU, the reagent being free of foreign matter, and

performance criteria by a failure to calibrate or generate results with an active calibration.

Mammot Inspiration Siemens AG 2010-10-03 2011-08-31 66721 Type I 10140000 N/A Lowering the swivel arm with "object table" while an operator's or a patient's body parts are

underneath the "object table" may cause the "object table" to collide with and injure the

operator or patient. The movement of the swivel arm may also cause an injury. During a

biopsy examination the swivel arm of the system might be tilted to somewhere between +15

and -15 degrees and when starting the examination to acquire stereo images, the swivel

arm may automatically move between +15 to -15 degrees. This movement may cause body

parts to be pinched or otherwise injured, particularly with seated or recumbent patients.

Vitek 2 Yeast Identification Card (YST) bioMérieux Inc. 2011-10-03 2011-09-02 66785 Type II N/A 243210940 There is a possibility of false positive results on QC strains for a specific lot of Vitek 2 Yeast

identification cards.

Medtronic SynchroMed II Implantable Programmable Drug

Pump

Medtronic Inc. 2011-10-03 2011-07-05 66803 Type II 8637-20, 8637-40 Not Lot Specific, Contact Manufacturer This field action is to provide an update to important safety information and patient

management recommendations related to the potential for reduced battery performance in a

small percentage of SynchroMed II pumps.

Therakos Cellex Photopheresis System Therakos Inc. 2011-10-03 2011-09-02 66808 Type II Therakos Cellex 40233, 40138, 40223, 40234 Of 18,000 treatments performed to date, Therakos received three confirmed reports of post

reinfusion hemolysis or hemoglobinuria in patients treated on the Cellex Photopheresis

system. The investigation suggests that heat generated in the centrifuge chamber may be

responsible for red cell changes that may rarely result in post reinfusion hemolysis or

hemoglobinuria. The purpose of the recall notification is to provide customers with

recommended actions intended to reduce heat build-up in the centrifuge chamber of the

Cellex system.

A) VITROS ECi/ECiQ Immunodiagnostic Systems Software V

3.8 & below / VITROS Immunodiagnostic Products Total beta-

hCG II Reagent Packs Lots 0484 & Above

B) VITROS ECi/ECiQ Immunodiagnostic Systems Software V

3.8 & below/VITROS Immunodiagnostic Products Total beta-

hCG II Reagent Packs Lots 0484 & Above

Ortho-Clinical Diagnostics Inc. 2011-10-03 2011-08-25 66825 Type II A) 8633893

B) 1922814

A) Lots 0484 and above

B) Lots 0484 and above

There is a software issue that may affect results from diluted samples run on the Vitros ECI

Immunodiagnostic System tested with the Vitros Immunodiagnostics products Total Beta-

HCG II Reagent pack. OCD has received complaints of observed results from diluted

samples that were reported as <2.39 Miu/ml (iu/l) instead of the correct 'no result', which is

accompanied by an invalid dilution (ID) code. The diluted results were inconsistent with

results from the neat (Undiluted) sample, which was within the measuring range of 2.39-

15,000 miu/ml.

Endodontic Reducer Contra Angle Handpiece Anthogyr 2011-10-03 2011-08-24 66901 Type III 815-9008, 815-9010 All Lots Product was not licenced until Sept 8, 2011.

Dimension EXL System (Troponin) TNI Assay Siemens Healthcare Diagnostics Inc. 2011-10-03 2011-09-02 66908 Type III RF621 ED2098, EA2111, FB2134, ED2147 There have been customer complaints for low recovery of QC and patient samples with

specified lots. Low patient results are due to troubleshooting following low recovery of QC.

Micrusphere Xl 10 Microcoil System Micrus Endovascular Corporation 2011-10-03 2011-09-09 66909 Type III SSR 100514-20 G10559, G10560 A typographical error may exist on the package label and peel-off stickers that are placed

on the packaging of certain Micrusphere XL 10 Microcoil systems. The product catalog

number on the package does not match the catalog number that was ordered. However, the

product inside the package is correct. Customers who ordered SSR 100514-20 (Micrusphere

XL 10, 5mm x 14cm) received product that was labeled SSR 100514-10 (Micrusphere XL

10, 5mm x 14cm). The -10 catalog number extension does not exist in the Micrus product

catalog.

Galileo Echo Instrument Immucor Inc. 2011-10-03 2011-09-09 66967 Type I 87000 All A customer reported an unexpected negative result in an Antibody Assay on the Galileo

Echo.

A) Amsco V-Pro 1 Low Temperature Sterilization System

B) Amsco V-Pro 1 Plus Low Temperature Sterilization System

Steris Mexico 2011-10-03 2011-09-14 66991 Type II A) VP10001101, VP10002101, VP10002102

B) VP20002101

A) S/N: 033640901, 030830903, 030400926,

030300909, 033650804, 032740804,

032750832, 032820802, 032460810

B) S/N: 030701116

Through customer feedback and field service experience, steris has learned that Amsco V-

Pro 1 and V-Pro 1 Plus low temperature sterilization systems users may experience

premature wear of the vacuum pump and filtering components. Users may also experience

incomplete aeration of the device's chamber following a failed leak test.

Symphony Automated Staining System Ventana Medical Systems Inc. 2011-10-03 2011-09-13 67043 Type III N/A P/N 06114270001, P/N 900-SYM3, S/N 390000

and higher

A significant volume of alcohol was reported to have leaked from Symphony Automated

Staining System onto the floor area surrounding the instrument which was identified as

potential slip and fall/or flammability.

Biolox Option Ceramic Femoral Heads Zimmer GMBH 2011-10-03 2011-09-15 67060 Type II 00877702801, 00877702802, 00877702803, 00877702804, 00877703201,

00877703202, 00877703203, 00877703204, 00877703601, 00877703602,

00877703603, 00877703604, 00877704001, 00877704002, 00877704003,

00877704004

> 10 Lots, Contact the Manufacturer Zimmer GMBH is initiating a recall by issuing a revised instructions for use (IFU) for the

Biolox Option Ceramic Femoral Head system, sizes 28mm to 40mm. Zimmer determined

that the current information as described in the IFU and in the design rational document was

confusing. The system offers the option to treat primary and revision cases. In hip revision

surgery, the original stem could remain in situ. For this specific scenario, the Biolox Option

IFU and the Design Rationale document related to the heads, have been revised to improve

the definition for the level of allowed damage for the stem taper.

A) Vaginal-Applicator Set

B) Stump Applicator Set

Varian Medical Systems Inc. 2011-10-17 2011-07-13 66008 Type II A) GM11002560

B) GM11002560

A) >10 Numbers Contact Manufacturer /

B) >10 Numbers Contact Manufacturer /

In previous recall (HC# 55250), this addressed the Flexible Applicator Probes that can

shrink by up to 2mm after autoclaving. It has been determined that a portion of the shipped

inventory of Flexible Applicator Probes was not heat annealed. This recall supplements

previous instructions by requring users to stop using any Flexible Applicator Probes that

may still be in inventory with lot numbers D01 to H14 inclusive. These applicator probes are

to be returned to Varian Brachytherapy for replacement with Lots after H14.

A) DLP Pressure Display with Remote Alarm Box

B) DLP Pressure Display Set

Medtronic Inc. 2011-10-17 2011-09-12 66935 Type III A) 60000, 63000, 64000, 66000

B) 61000, 61006, 62000, 62006



The purpose of this field action is to inform customers of issues related to the Directions for

Use (DFU) provided with the pressure display box and pressure display set. These issues

are accuracy in the negative pressure range and length of use.

Medtronic has become aware that the pressure display box may not always accurately

display readings. The negative pressure inaccuracy is relevant in applications involving

"high vacuum" settings. These applications would be vacuum assisted venous drainage

(VAVD), and port access/mini sternotomy procedures.

When used for an extended period (>24 hours) the positive pressure display may drift due

to air leakage in the system.

A) Advia 120 Hematology System - Analyzer

B) Advia 2120i Analyzer with Autosampler with Auto Waste

C) Advia 2120i Analyzer with Autosampler with Manual Waste

D) Advia 2120i Analyzer Without Autosampler with Manual

Waste

E) Advia 2120 with Dual Aspiration Autosampler

F) Advia 2120 Without Autosampler

G) Advia 2120 with Autosampler

Siemens Healthcare Diagnostics Inc. 2011-10-17 2011-09-14 67005 Type III A) 10310973, 10317457

B) 10284942, 10361798

C) 10361802, 10361803

D) 10361793, 10361794

E) 10313419

F) 10315687

G) 10316162

A) N/A

B) N/A

C) N/A

D) N/A

E) N/A

F) N/A

G) N/A

Customer complaint received that during troubleshooting a syringe filled with EZ Kleen was

connected to the Perox 2 Reagent tubing. The EZ Kleen sprayed on the operator's forehead

after the syringe plunger causing the Tygon tubing to disconnect at the check valve.

T-Pal Spacer Brochure Synthes (Canada) Inc. 2011-10-17 2011-09-13 67098 Type III 08.812.007, 08.812.008, 08.812.009, 08.812.010, 08.812.011, 08.812.012,

08.812.013, 08.812.014, 08.812.015, 08.812.016, 08.812.017, 08.812.207,

08.812.208, 08.812.209, 08.812.210, 08.812.211, 08.812.212, 08.812.213,

08.812.214, 08.812.215, 08.812.216, 08.812.217

N/A Synthes (Canada), Ltd. Is initiating a medical device labelling recall related to the Synthes T-

Pal Spacer System, specifically regarding the use of the T-Pal Spacer with Allograft

material. This action has been initiated following a regulatory review of all labelling and

promotional materials associated with the T-P-pal Spacer System which is currently only

indicated for use with Autograft. There have been no additional risks to the patient

identified, associated with the use of the T-Pal Spacer System with Allograft material.

LifeCycle for Prenatal Screening Wallac OY 2011-10-17 2011-08-12 66240 Type II 5002-0020 v.3.0, v.3.1, v.3.2 Limitations of repeated measures testing in cross-trimester screening.

A) SonoSite M-Turbo Ultrasound System

B) MicroMaxx Ultrasound System, C3.4.3 ABT

SonoSite Inc. 2011-10-17 2011-09-02 66474 Type II A) P08189

B) P08840


B) WK03LN, WK03QQ, WK037Q, WK02T6

During the development process on a research product platform, Sonosite discovered a

data (Ratio) display anomaly for a specific calculation within the extended OB/GYN

Calculation software package. The anomaly exists on the noted M-Turbo and Micromaxx

Ultrasound Systems when enabled with the extended OB?GYN Calculation package. While

performing a systolic/diastolic (S/D) ratio measurement, if the systolic caliper is repositioned

after setting the diastolic cursor, the S/D ratio shown at the bottom of the display screen is

not updated to reflect the new ratio value (but the correct S/D ratio is printed on patient

reports).

A) Eius Knee System - Femoral Components

B) Eius Knee System - Tibial Components

Howmedica Osteonics Corporation 2011-10-17 2011-09-01 66890 Type II A) 6636-2-001, 6636-2-002, 6636-2-003, 6636-2-004, 6636-2-005, 6636-2-011,

6636-2-012, 6636-2-013, 6636-2-014, 6636-2-015

B) 6636-2-308, 6636-2-309, 6636-2-310, 6636-2-312, 6636-2-318, 6636-2-319,

6636-2-320, 6636-2-322, 6636-2-408, 6636-2-409, 6636-2-410, 6636-2-412, 6636-

2-418, 6636-2-419, 6636-2-420, 6636-2-422, 6636-2-508, 6636-2-509, 6636-2-510,

6636-2-512, 6636-2-518, 6636-2-519, 6636-2-520, 6636-2-522, 6636-2-608, 6636-

2-609, 6636-2-610, 6636-2-612, 6636-2-618, 6636-2-619, 6636-2-620, 6636-2-622,

6636-2-708, 6636-2-709, 6636-2-710, 6636-2-712, 6636-2-718, 6636-2-719, 6636-

2-720, 6636-2-722

A) All

B) All

Stryker was aware that the revision rates associated with the Eius Knee System were higher

than other similar devices.

Bardport Titanium Implanted Port Bard Access Systems Inc. 2011-10-17 2011-09-23 67235 Type III 602290 RESF1061, RESI0209, RESK0806, RETA0584 There is a labeling discrepancy specific to listed lot numbers of Bardport Titanium Implanted

Port (PC 0602290). The end flap label indicates a different product description as compared

to the main label. The main label identifies the port as a "Titanium Implanted Port", while

the end flap identifies the port as a "Titanium Low-Profile Implanted Port". The product

inside the kit is a regular port and not a low-profile port.

Magnus Hybrid operating table columns Maquet Gmbh & Co. KG 2011-10-17 2011-09-08 66892 Type II 1180.01A1 23 A complaint with a system in which the inability to perform rotational angiography occurred

twice. The cause was traced to a sensor in the magnus column as a result of an incorrect

signal from this sensor, all high-speed movements of the C-Arc were blocked. An incorrect

signal can have an effect, during high-speed applications of the allura system (3DRA,

Xperct, Xperswing). If the fault occurs during daily xperct calibration, this function will not be

available. If the fault occurs prior to or during a high-speed application, the acquisition

cannot be set-up and the movement function of both the C-Arc and the magnus operating

table are locked. The described fault does not affect other functions of the system.

Variant II B-Thalassemia Short Program Reorder Pack Bio-Rad Laboratories Diagnostics Group 2011-10-17 2011-09-19 67167 Type III 2702154 2702154 The sodium content of some elution buffers could be altered, which would cause calibration

failures.

Contour Blood Glucose Test Strips Bayer Healthcare LLC Subsidiary of Bayer Corporation 2011-10-17 2011-09-22 67227 Type III 9546B, 9546C, 9586, 9586A >10 Numbers Contact Manufacturer Bayer has issued a global stop on new shipments of the 5-, 10-, and 25-count vials of

Contour, Contour Link, and Contour TS blood glucose test strips out of an abundance of

caution to address a packaging issue discovered during routine internal quality testing. It

was identified that under certain conditions, some test strips in some 5-, 10-, or 25-count

vials can produce a low bias reading during blood glucose testing.

A) Nucleus CI500 Cochlear Implant Series

B) Nucleus CI500 Cochlear Implant Series

Cochlear Limited 2011-10-17 2011-09-19 67074 Type II A) Z209051

B) Z110048

A) >10 Numbers Contact Manufacturer

B) >10 Numbers Contact Manufacturer

Implant can experience intermittent behaviour that leads to safe shut down and cessation of

function. Failed units require explant and replacement.

A) Zero-P Technique Guide - Parallel Sterile

B) Zero-P Technique Guide - Lordotic Sterile

C) Zero-P Technique Guide - Convex Sterile

Synthes (Canada) Inc. 2011-10-17 2011-09-13 67099 Type III A) 04.617.110S, 04.617.111S, 04.617.112S, 04.617.115S, 04.617.116S,

04.617.117S, 04.617.118S, 04.617.119S

B) 04.617.120S, 04.617.121S, 04.617.122S, 04.617.125S, 04.617.126S,

04.617.127S, 04.617.128S, 04.617.129S

C) 04.617.130S, 04.617.131S, 04.617.132S, 04.617.135S, 04.617.136S,

04.617.137S, 04.617.138S, 04.617.139S

A) All

B) All

C) All

Synthes Canada is initiating a medical device labelling recall related to the Synthes Zero-P

instrument and implants technique guide, document #J8566, revision C and previous that

references the use of Peek-CR as a cervical interbody spacer. Peek-CR is not currently

indicated for use as cervical interbody spacer. There have been no additional risks to the

patient identified that are associated with the use of the Peek-CR as a cervical interbody

spacer.

D-10 Hemoglobin A1C Program Reorder Pack Bio-Rad Laboratories Diagnostics Group 2011-10-17 2011-09-19 67173 Type III N/A 20010946, 20011075, 20011077, 20011079,

20011081

Sodium content of certain elution buffer could be altered, which would result in calibration

failures.

Synchrony Respiratory Tracking System Accuray Inc. 2011-10-17 2011-09-12 67213 Type II 026429, 026430, 028185, 028186 C0231, C0202, C0238 The boom arm of the Synchrony Camera Array mounting assembly could unexpectedly

detach from the mounting pole during manipulation by the user.

CyberKnife Standard Treatment Couch Accuray Inc. 2011-10-17 2011-09-16 67217 Type II N/A C0231, C0202, C0238 A user reported the standard treatment couch table top had partially detached from the

support column and descended to the floor. There was no patient involved. No serious

injury was reported by the user.

Adult Disposable Manual Resuscitator BOMImed Inc. 2011-10-17 2011-09-14 67267 Type II OL-500101-00, OL-500102-00 072111, 082411, 082511, 082611, 082911,

090711

The part number on the product labels for the disposable Adult Manual Resuscitators

substitution is incorrect. The products were sent out as OL-500100-00 and should have

been labeled OL-500102-00 and/or 500101-00. This was brought to Bomimed's attention

september 12, 2011.

VISX Excimer Laser System - Star S4 IR AMO Manufacturing USA, LLC 2011-10-17 2011-07-22 66069 Type II Star S4 IR >10 Numbers Contact Manufacturer Pupil Centroid Shift Compensation is not functioning as intended in the Iris Registration (IR)

software, versions 5.00 through 5.30. As a result, the center of the ablation pattern may not

be optimally aligned. This may, in some cases, result in visual disturbances or reduced best

corrected visual acuity.

Nipro Bloodline Nipro Corporation 2011-10-17 2011-09-07 66987 Type II A230TR/V810TR 10F16, 10F18, 10F19 The mini clamps used on the Transducer Protector line of the Venous line are manufactured

from materials not suitable for gamma sterilization causing them to crack and break. Nipro

Medical corporation received two complaints from Baxter Corporation Canada regarding the

defective clamps.

Dimesion EXL System-(Troponin) TNI Assay Siemens Healthcare Diagnostics Inc. 2011-10-17 2011-09-02 67201 Type II RF621 ED2098, EA2111, FB2134, ED2147 Internal testing has confirmed low recovery of QC and patient samples. Use of one of these

lots may show a downward shift in QC and patient results. This decrease may cause a

sample that is slightly above the 99th percentile (0.056 ng/ml) of a reference population to

read below this value. At higher values of TNI, samples will remain positive and the bias is

not clinically significant.

Brightview XCT Imaging System-Tilt System Philips Medical Systems (Cleveland) Inc. 2011-10-17 2011-09-21 67203 Type II 453560462131, 453560749161 N/A Philips will be providing a software upgrade to Brightview XCT system customers to

improve the functionality of the device and correct several issues that either have no

identified hazards or have been determined to have minimal risk.

A) On-Board Imager

B) Clinac IX High Energy Linear Accelerator

C) Trilogy High Energy Linear Accelerator

D) Clinac 21EX High Energy Linear Accelerator

Varian Medical Systems Inc. 2011-10-17 2011-05-24 65613 Type II A) N/A

B) N/A

C) N/A

D) N/A

A) H080194, H080268, H080213, H080217,

H080059, H082103, H080060, H080286,

H080220

B) H291178, H291016, H293307, H291021,

H291194

C) H291166, H291172

D) H272370, H272407

An anomaly has been identified with the High - Energy Clinac Gantry Center Throat Cover

where the cover may lean toward isocenter far enough to strike a patient. This issue is

limited to center throat covers on high energy clinacs (H14, H27, H29) with V1.0 of the Obi

KV Imaging System. These covers are associated with the Obi Air-Cooled KV X-Ray tube.

Other center throat covers use a different design.

Syngo Dynamics Siemens Medical Solutions USA Inc. 2011-10-17 2011-09-13 67285 Type III 100-90-480 N/A If one or more graphs are in a table on the report, and if any of those graphs are deleted, it

may lead to the following unexpected behaviour: 1) Any changes made to the report since

the last saved version will not be saved. 2) Marking the study as read (clicking the verify

button) might leave the study in an unread state or might mark the study as read but leave

the report with a "preliminary" watermark displayed.

Steri-Drape Roll Prep Drape 3M Health Care 2011-10-17 2011-09-26 67371 Type III 1000NSR 2013-O3 AC, 2013-O3 AD, 2016-03 AY, 2016-

03 BA

Drape is not unwinding from the roll, making the product unusable.

Juan/Thermo-Fisher Centrifuge Model C4i Tripath Imaging, Inc. 2011-10-17 2011-07-05 66857 Type III 799-13000-00, 799-14000-00 All A software error in the Juan/Thermo-Fisher C4i Centrifuge sold with the Prepstain system

causes the centrifuge to display an inaccurate G force or RPM reading during operation. In

each case that has been investigated, the centrifuge was operating properly, but the display

was showing a value that was lower than the true value.

A) Cruiser Hydro Coronary and Peripheral Artery Guide Wire

HF

B) Cruiser Hydro Coronary and Peripheral Artery Guide Wire F

C) Cruiser Hydro Coronary and Peripheral Artery Guide Wire

M

D) Cruiser Hydro Coronary and Peripheral Artery Guide Wire

ES-HF

E) Cruiser Hydro Coronary and Peripheral Artery Guide Wire

ES-F

Biotronik AG 2011-10-17 2011-09-07 66925 Type II A) 351455

B) 351456

C) 351457

D) 351458

E) 351459



C) 08099006, 10099007, 10099008, 01109001,

01109002

D) >10 Numbers Contact Manufacturer /

E) 9099001, 10099001, 10099003, 02109003

Specific lots potentially have decreased tensile strength of the Distal Tip when tested at

three year shelf-life. Two year shelf-life dated product is not affected.

Slidex Staph Plus bioMérieux SA 2011-10-17 2011-09-09 66969 Type II 73115, 73116 1102104106, 1012103761, 1011103665,

1012103706

A problem with R1 Reagent specificity (Anti-Staphylococcus Aureus Latex) could lead to

false positive results with Staphylococcus Non-Aureus strains.

Panocell-10 Immucor Inc. 2011-10-17 2011-09-19 67149 Type III 3032 33142 The following antigens are incorrectly listed as negative on the supplemental unconfirmed

typings for Cell 5 (Donor E841): I, GE, TJA, VEL, YTA, DIB, and U. Cell 5 is positive for the

I, GE, TJA, VEL, YTA, DIB, and U antigens.

Bartels Clostridium Difficile Antioxin Mardx Diagnostics Inc., a Trinity Biotech Company 2011-10-17 2011-08-31 67376 Type III B1029-70C K-949 Quality Control Department has detected the presence of a mold contaminant in the

antitoxin reagent.

Berichrom Pai Siemens Healthcare Diagnostics Products GMBH 2011-10-17 2011-09-26 67378 Type III OWOA15 541572 Specified lot can result in clinical significant lower Pai values compared to previous lots.

High Pai concentrations (>10 u/ml) might be underestimated and in the low reference range

patient results might be found even below the reference range.

Level Sensor II Pads, Gel Included Terumo Cardiovascular Systems Corp. 2011-10-31 2011-09-30 67277 Type II 195240 > 10 Numbers, Contact the Manufacturer Pads detaching from the surface of the venous reservoir. Pads exhibited reduced adhesion

to the reservoir surface.

A) NCS Strep A Twist Rapid Test Device

B) NCS Strep A Rapid Test Device

Nova Century Scientific Inc. 2011-10-31 2011-09-21 67280 Type II A) NCS-502T

B) NCS-502

A) 0060010, 0060032, 0100050, 8100037,

8100040, 9010062, 9080038

B) 0060011, 1010001, 1030052, 1040066,

1070036, 8110066, 9010101, 9030062,

9030135, 0960069

Through testing it was determined that this product may have an elevated incidence of false

positive results. A false positive test result could lead to the administration of antibiotics that

are unnecessary. As with all diagnostic tests, all results must be interpreted together with

other clinical information available to the physician. The root cause is still under

investigation.

Philips NM3 Monitor Respironics Novametrix, LLC 2011-10-31 2011-08-29 67464 Type II 1051674 00428, 00350, 00409 Some units exhibit a mechanical problem that could result in the display of incorrect tidal

and minute volumes. Inaccurate data could lead to an incorrect treatment for mechanically

ventilated patients. This can lead to high PCO2 and low PH level in the patient.

A) coDiagnostiX station

B) coDiagnostiX PPP

C) Online Upgrade coDiagnostiX Station

D) coDiagnostiX coDoctor

Institut Straumann AG 2011-10-31 2011-08-02 66015 Type II A) 019.0372

B) 019.0370

C) 019.0386

D) 019.0387

A) N/A

B) N/A

C) N/A

D) N/A

If user changes the implant length after the planning stage has been completed with the

2.8mm slkeeve, the software does not recognize the change.

Panocell-10 Immucor Inc. 2011-10-31 2011-09-19 67149 Type III 3032 33142 The following antigens are incorrectly listed as negative on the supplemental unconfirmed

typings for Cell 5 (Donor E841): I, GE, TJA, VEL, YTA, DIB, and U. Cell 5 is positive for the

I, GE, TJA, VEL, YTA, DIB, and U antigens.

A) Access System - Total T4 Assay

B) Unicel Dxi 600 Access Immunoassay System - Total T4

Assay

C) Unicel Dxi 800 Access Immunoassay System - Total T4

Assay

Beckman Coulter Inc. 2011-10-31 2011-03-07 62307 Type II A) 33800

B) 33800

C) 33800

A) All Reagent Packs

B) All Reagent Packs

C) All Reagent Packs

The concentration of Total T4 in samples from pregnant women is erroneously low when

measured using the access Total T4 assay.

Entroy Pool Lift Arjo Hospital Equipment AB 2011-10-31 2011-07-14 66513 Type II GAB1000-01-US, GAB1000-01-XX,

GAB1000-11-XX, GAC100X

N/A A design flaw in the Actuator suspension may allow booms to lower quickly, un-commanded

to the bottom of its stroke. The defect renders the lift inoperable and my result in serious

injury.

Encore100 Toric Soft Contact Lens CooperVison Inc. 2011-10-31 2011-08-19 66568 Type II N/A > 1000 Numbers, Contact Manufacturer, There is unintended presence of a residue on lenses from certain lots of Encore100 Toric

contact lenses. The company received complaints of temporary hazy or blurry vision, and

discomfort, most likely caused by transient or reversible swelling of the surface layer of the

cornea, which is known as corneal epithelial edema.

Tremblay Harrison Minute Lab Strep A Rapid Test Device Tremblay Harrison Inc. 2011-10-31 2011-09-18 67276 Type III STW-A1 STA0010072, STA0110106, STA0110011,

STA0100087

Through testing it was determined that this product may have an elevated incidence of false

positive results. A false positive test result could lead to the administration of antibiotics that

are unnecessary. As with all diagnostic tests, all results must be interpreted together with

other clinical information available to the physician. The root cause is still under

investigation.

Active IGFBP-3 Elisa (Insulin like Growth Hormone) Beckman Coulter Inc. 2011-10-31 2011-03-28 62595 Type II DSL-10-6600 990220, 991432, 991530, 991916, 992287 The absolute range of IGFBP-3 levels determined using DSL-10-6600 IGFBP-3 Elisa, lot

number 992743, is 3196 -10007 ng/ml. This is approximately 1.7 fold higher than the

absolute range reported in the ifu (1500 - 5600 ng/ml).

Immage Immunochemistry System RF Rheumatoid Factor

Reagent

Beckman Coulter Inc. 2011-10-31 2011-05-31 64398 Type III 447070 M908398, M911529 Beckman Coulter has confirmed that for lot numbers M908398 and M911529 of Immager

Immunochemistry Systems Rheumatoid Factor Reagent, known negative results are being

reported as slightly positive (between 20 and 30 iu/ml, usually). When tested on other

methods or with other lots most of these slightly positive samples read < 20 iu/ml or

negative. Per the CIS 95% of normal, healthy individuals who live in southern California

should have results less than 20 iu/ml. Customers utilizing these lots are reporting patient

results in more than 5% of their samples with results greater than 20 iu/ml.

Senographe 2000D Mammography System GE Medical Systems SCS 2011-10-31 2011-10-12 67204 Type II S30321PZ 298660BU2, 379686BU9, 306445BU8,

420009BU3, 3364668BU2

Some Pacs and Workstations vendors implement a distance measurement calculation that

is IHE compliant for magnified images. When sending magnified images acquired by GE

Senographe 2000D Mammography Systems to these workstations, distance measurement

may be inaccurate and the caregiver may underestimate a breast lesion/tumor. This issue

does not exist for images done with contact mode. A combination of pixel spacing dicom

tags and estimated radiographic magnification dicom tag, influence the measurement result

of the magnified images on the diagnostic review workstation. In the mammography

industry, the pixel spacing information has been coded in different ways since the

introduction of digital images. The IHE Initiative established a clear recommendation,

however, it has not been implemented by all systems. As the first company to create digital

mammography images, GE has implemented a specific codification of the calibration of

pixel size information that is not consistent with the more recent IHE recommendation. GE

Senographe 2000D Full Field Digital Mammography System ( Seno2000D) systems

implement this GE coding schema. Some non-GE review workstations may not be able to

interpret this type of coding properly. Therefore, distance measurements on GE magnified

images that are pushed to certain non-GE review workstations could cause lesion size

measurement errors on magnified views. Additionally true size display or true size printing

of magnified views on Dicom printers can also be affected. All GE multisystem review

workstations (Seno Advantage 2.x and IDI) are now able to identify and correctly interpret

both GE coding and ihe coding. GE Seno Advantage 1.x Review Workstation can only read

GE coding.

Rapid Strand Rx Pre-loaded Brachytherapy Kit Medi-Physics Inc., D.B.A. GE Healthcare 2011-10-31 2011-09-20 67281 Type II I125RSRX-ROUND N/A First field complaint received 05 May 11 from Poole Hospital NHS Foundation, UK. Receipt

of RSRX product that was observed to measure approximately 16% below the activity

stated within the associated i-125 sealed source calibration certificate (0.449 MCI). Second

field complaint received may 18 from San Sebastian where the calibration strand was

assayed and activity found to deviate from label by 8.3%. Two additional complaints were

the orders determined to be mixed with Poole and San Sebastian.

A) Precedence System-16 Slice

B) Precedence System-6 Slice

C) Skylight Gamma Camera System

Philips Medical Systems (Cleveland), Inc. 2011-10-31 2011-09-30 67583 Type II A) 2619-3000A

B) 2169-3002A

C) 2160-3000A, 2160-3000B, 2161-3000B, 2161-3001B

A) N/A

B) N/A

C) N/A

A button on the hand controller on the precedence and Skylight Spect Systems may

become stuck, which may result in unintended motion of the detector which could cause the

detector to come in contact with the patient if the operator is not diligently observing the

scan.

Tobramycin Assay Siemens Healthcare Diagnotsics Inc. 2011-10-31 2011-10-04 67585 Type III 00835186, 03329524 >20 Lot Numbers, Contact Manufacturer Reagents of specified lots failed QC requirements while within the assay stored calibration

and onboard stability claims of 7 and 14 days respectively. This issue is detected through

routine QC monitoring where results are out of the expected range values resulting in the

failure of the Tobramycin Assay to meet the onboard stability claim.

A) BV Pulsera Mobile C-Arm System-9 In. And 12 In. Versions

B) BV Endura Mobile C-Arm System

C) Veradius

Philips Medical Systems Nederland BV 2011-10-31 2011-10-03 67586 Type II A) 718095

B) 718074

C) Veradius

A) N/A

B) N/A

C) N/A

A problem was found during production with the part designed to mechanically connect the

C-Arm to the stand. Due to an unintended external force, the front plate in this part broke

into two pieces causing the C-Arm to suspend on the single central bolt. If this problem were

to reoccur in the field, it could pose a risk for patients and others in close vicinity to the

system.



Hospira Inc. 2011-11-14 2011-09-20 67069 Type II A) 12391, 20679, 20792

B) 12678, 20678

A) >100 Numbers, Contact Manufacturer,

>100 Numéros, Contactez Fabriquant

B) >100 Numbers, Contact Manufacturer,


Continuous recycling and/or rebooting of Plum A+ devices (single and triple channel) may

occur when the "backlight intensity" and/or "display contrast" settings for the lcd display

have been adjusted from the original default setting. / Un recyclage et/ou une réinitialisation

en continu des dispositifs Plum A+ (à canal simple ou triple) peuvent se produire lorsque les

paramètres d'« intensité du rétroéclairage » ou de «contraste de l'affichage» de l'écran ACL

ont été modifiés.

Thyroxine (T4) Assay Siemens Healthcare Diagnostics Inc. 2011-11-14 2011-10-07 67589 Type III 08074354, 09236439 >10 Numbers, Contact Manufacturer,


Specified lots are not meeting the onboard stability claims. This issue is detected through

routine quality control monitoring. QC results are out of the expected range values. / Les

lots spécifiés ne respectent pas les exigences en matière de stabilité en cours. Ce problème

a été identifié pendant la surveillance de contrôle de la qualité courante, où des résultats

étaient en dehors de la plage de valeurs prévues.

A) PCR Eleva S

B) PCR Eleva S Plus

C) PCR AC-500 / PCR AC-5000 Basic System

D) PCR Eleva Corado

Philips Medical Systems DMC GMBH 2011-11-14 2011-10-12 67759 Type II A) PCR Eleva S

B) PCR Eleva S Plus

C) 989701000002

D) PCR Eleva Corado

A) N/A

B) N/A

C) N/A

D) N/A

Philips has reports that the burned in mirror icon has been criticized by customers. The

mirror icon could be interpretted as a right marker if the image is mirrored again within the

PACS system. This could lead to a misdiagnosis. / La compagnie Philips a reçu des plaintes

de clients relativement à l'icône en miroir imprimée, qui pourrait être prise à tort pour le côté

droit du patient si l'image est reproduite en miroir dans le système PACS, ce qui pourrait

entraîner une erreur de diagnostic.

A) Accent DR

B) Accent DR RF

C) Anthem CRT-P

D) Anthem CRT-P RF

St. Jude Medical, Cardiac Rhythm Management Division 2011-11-14 2011-09-22 67287 Type II A) PM2112

B) PM2212

C) PM3112

D) PM3212

A) N/A

B) N/A

C) N/A

D) N/A

There is a potential for a small amount of charge to build and be stored on the capacitor in

between automatic daily measurements. This residual charge may result in an artificially low

displayed lead impedance value in some cases. / Il existe un risque qu'une petite quantité

de charge s'accumule sur le condensateur entre les prises de mesures automatiques

quotidiennes. Cette charge résiduelle peut entraîner une lecture artificiellement faible de la

valeur d'impédance de la sonde dans certains cas.



Hospira Inc. 2011-11-14 2011-09-20 67860 Type I A) 12391, 20679, 20792

B) 12678, 20678





Hospira received complaints relating to incorrect seating of the regulator closer. As a result

of this failure, unrestricted flow may occur which could contribute to life-threatening adverse

events. / Hospira a reçu des plaintes relativement à une mauvaise disposition du dispositif

de fermeture du régulateur. En raison de cette défaillance, les liquides peuvent s'écouler

sans restriction, ce qui pourrait contribuer à créer des événements indésirables comportant

un danger de mort.

A) Drills / B) Burr - Diamond Ball

C) Burr - Twist Drill /D) Burr - Fluted Ball

E) Burr - Coarse Diamond Ball / F) Burr - Fluted Router

G) Burr - Extra Coarse Diamond Ball

H) Burr - Fluted Oval / I) Burr - Fluted Acorn

J) Burr - Coarse Diamond Drum

K) Burr - Extra Coarse Diamond Drum

L) Burr - Fluted Pear / M) Burr - Fluted Matchstick

N) Burr - Diamond Matchstick

O) Burr - Diamond Disc / P) Burr - Side Cutter

Q) Burr - Fluted Drum / R) Burr - Spiral Router

S) Burr - Fluted Carbide Drum / T) Burr - Coring Tool

U) Burr - Diamond Flame / V) Irrigation Clip

W) Minimal Access Attachment System - Fluted Ball

X) Minimal Access Attachment System - Diamond Ball

Y) Minimal Access Attachment System - Coarse Diamond

Z) Minimal Access Attachment System - Fluted Matchstick

AA) Quick Disconnect Angle Attachment - Fluted Ball

BB) Quick Disconnect Angle Attachment - Diamond Ball

CC) Quick Disconnect Angle Attachment - Coarse Diamond Ball

DD) Quick Disconnect Angle Attachment - Extra Coarse Diamond Ball

EE) Quick Disconnect Angle Attachment - Fluted Oval

FF) Quick Disconnect Angle Attachment - Fluted Matchstick

GG) Quick Disconnect Angle Attachment - Fluted Drum

HH) Micro Dissection Attachment System - Fluted Ball

II) Micro Dissection Attachment System - Diamond Ball

JJ) IMRI Fluted Ball / KK) Burr - Carbide Fluted Ball

LL) Boring Tool

The Anspach Effort Inc. 2011-11-14 2011-09-09 67146 Type II A) ADG-11, ADG-13

B) BLU-17-5, L-5D, L-6D, M-1B, M-2D, M-2SD, M-3D, M-6B, M-7B, MIA 16-4D, S-05D, S-15D, S-15SD, S-

1D, S-1SD, S-25D, S-25SD, S-2D, S-2SD, S-35D, S-3D, S-3SD, S-4D, S-5D, S-6D, SIL-17-3, SIL-17-6,

TURQ-17-3, TURQ-17-5, TURQ-L17-3, VIO-17-2, VIO-17-3, VIO-17-5 / C) S-1254TD, S-1504TD, S-

1506TD, TURQ-436-6

D) BLA-7-9, BLU-6, BLU-7-9, L-2SB, L-3SB, L-3SD, L-4B, L-5B, L-6B, LHD-7B, M-2SB, M-3SB, M-4B, M-

8NS, RED-5, S-15B, S-15SB, S-1B, S-25B, S-25SB, S-2B, S-35B, S-35SB, S-3B, S-3SB, S-4B, S-5B, S-

6B, S-7B, S-8B, S-9B, SHD-6B, SIL-3, SIL-4, SIL-5, SIL-6, SIL-7, SIL-7-9, TURQ-L3, TURQ-L4, TURQ-

L5, TURQ-L5, TURQ-L6, VIO-6 /E) L-3SDC, L-4DC, L-5DC, M-1SD, M-2B, M-3B, M-4DC, S-25DC, S-

25SDC, S-2DC, S-3DC, S-3SDC, S-4DC, S-5DC, S-6DC, S-8DC, TURQ-L17-75C / F) A-CRN, BLA-1,

BLA-2, BLA-7, BLU-2XL, CDA-IR, GRE-1, L-1R, L-CRN, P-CRN, RED-1, S-1R, S-6R, SHD-6R, SIL-0,

SIL-1,SIL-2, TURQ-1, VIO-1, VIO-2, VIO-2XL, XLHD-25HR

G) L-4DX, S-4DX, S-5DX, S-6DX / H) M-5D, S-40V, VIO-40-4

I) BLU-32, BLU-38, M-5DC, RED-32, RED-38, S-5AC, S-6AC, S-9AC, SHD-6AC, SHD-75AC, SHD-9AC,

SIL-32, SIL-38, VIO-32, XLHD-75AC / J) S-68DRMDC / K) BLU-9DCX /L) SIL-21

M) BLU-8, GREY-MIA- 20-8, L-8N, L-8NS, L-8NS-M, M-8NSD, MHD-15C, S-8N, S-8N-18, S-8NS, S-8NS-

M, SHD-8NS, SIL-8, TURQ-8, TURQ-L8, TURQ-L8-18, VIO-8, XLHD-8NS

N) M-8NS, MHD-16CT, SIL-8D-32 / O) BLU-14, MHD-25DD, SHD-17DD, SHD-25DD, SIL-14, SIL-14-17,

VIO-14

P) SIL-15 / Q) BLA-9, L-35DR, LHD-64DRM, RED-9, XLHD-95DRM / R) A-CRN-S, ADG-10, GRE-1S, L-

CRN-S / S) MHD-3DRMC / T) MHD-19CT / U) M-5B / V) IRR-CLIP-10, IRR-CLIP-20, IRR-CLIP-40, IRR-

CLIP-50, IRR-CLIP-60 / W) MA10-2SB, MA15-2SB, MA15-3SB / X) MA10-2SD, MA15-2SD, MA15-3SD,

MA15-4D

Y) MA15-8NSDC / Z) MA15-8N, MA15-8NS / AA) QD11-2SB, QD11-3SB, QD11-4B, QD11-5B, QD11-6B,

QD14-3SB, QD14-4B, QD14-5B, QD14-6B, QD8-2SB, QD8-3SB, QD8-4B, QD8-5B, QD8-6B

BB) QD11-3SD. QD11-5D, QD14-4D, QD8-1SD, QD8-25SD, QD8-2SD, QD8-3SD, QD8-4D, QD8-5D

CC) QD11-4DC, QD11-5DC, QD8-3SDC, QD8-4DC / DD) QD11-5DX / EE) QD8-40V

FF) QD11-8N, QD11-8NS, QD14-8N, QD14-8NS, QD8-8N, QD8-8N-18, QD8-8NS / GG) QD11-4DRM

HH) MDA-2SB, MDA-3SB / II) MDA-2SD, MDA-3SD, MDA-4D

JJ) IMRI-SHD-6B / KK) S-2B-C, S-3B-C, S-4BL-C, S-5B-C

LL) MHD-97B, MHD-98B, SIL-20, SIL-24

A) >10 Numbers, Contact Manufacturer, > 10 Numéros, Contactez

Fabriquant / B) >10 Numbers, Contact Manufacturer, / > 10 Numéros,

Contactez Fabriquant

C) >10 Numbers, Contact Manufacturer, / > 10 Numéros, Contactez

Fabriquant / D) >10 Numbers, Contact Manufacturer, / > 10 Numéros,

Contactez Fabriquant / E) >10 Numbers, Contact Manufacturer,

> 10 Numéros, Contactez Fabriquant / F) >10 Numbers, Contact

Manufact urer, / > 10 Numéros, Contactez Fabriquant / G)

B453013691, 333305, 330625, 333623, 318537, 333620,334122,

334181, 333286 / H) 318472, 335184, 334555, 333162 / I) >10

Numbers, Contact Manufacturer, / > 10 Numéros, Contactez

Fabriquant

J) C463028160, B263009386, C103018318, B103005206,

C113018978, B163006632, C053017429, B333010929, B033002563 /

K) B273009628 /L) D143031700 / M) >10 Numbers, Contact

Manufacturer, / > 10 Numéros, Contactez Fabriquant / N) 319516,

C303023967, A503001714, C533029521, C503029185, 320176,

B0403003015, 330793, 332554 / O) >10 Numbers, Contact

Manufacturer, / > 10 Numéros, Contactez Fabriquant / P) >10


Fabriquant / Q) >10 Numbers, Contact Manufacturer, / > 10 Numéros,

Contactez Fabriquant / R) >10 Numbers, Contact Manufacturer, / > 10

Numéros, Contactez Fabriquant / S) B073004259 / T) B183006740 /

U) >10 Numbers, Contact Manufacturer, / > 10 Numéros, Contactez

Fabriquant / V) >10 Numbers, Contact Manufacturer, / > 10 Numéros,

Contactez Fabriquant / W) C493028995, B383012019, C233019979,

B033002458, A513001743 / X) C503029180, B133005832,

B153006396, B113005451, B093004851, A513001763, A513001821 /

Y) C293023615 / Z) B493014178, C213021949, C363025427,

C383025888 / AA) >10 Numbers, Contact Manufacturer, / > 10

Numéros, Contactez Fabriquant / BB) >10 Numbers, Contact

Manufacturer, > 10 Numéros, Contactez Fabriquant / CC) 330061,

330834, 332184, 333498, 334163, 332482, B503014848, B043003143,

A513001783, 332842, 331129 / DD) >10 Numbers, Contact

Manufacturer,

> 10 Numéros, Contactez Fabriquant / EE) 332291, 331887 / FF) >10


Fabriquant / GG) 320193, 330423, 330709, 333007 / HH) >10


Fabriquant / II) >10 Numbers, Contact Manufacturer, > 10 Numéros,

Contactez Fabriquant / JJ) 333148 / KK) B053003293, B463014365,

B453013945, B453013962, C023014787 / LL) >10 Numbers, Contact

Failure in the packaging configuration (packaged in a tyvek pouch/tube configuration) that is

not capable of maintaining a sterile barrier through the labelled shelf life of five years. / Une

mauvaise configuration d'emballage (sachet/tube tyvek) qui ne pourrait pas maintenir une

barrière stérile durant la durée de conservation de cinq ans inscrite sur l'étiquette.

Cobas Integra Theophylline for Cobas C Systems Roche Diagnostics GMBH 2011-11-14 2011-09-29 67460 Type III 4491025190 64020901 A possible elevated recovery in patient samples is observed with the Cobas Integra

Theophylline for Cobas C Systems of lot # 64020901. / Un possible rétablissement plus

élevé est observé dans les échantillons de patients avec la théophylline Cobas Integra pour

systèmes Cobas C du lot 64020901.

Cobas E 411 Immunoassay Analyzer Roche Diagnostics GMBH 2011-11-14 2011-10-06 67569 Type III 04775201001, 04775279001 N/A The pinch valve tubing has to be exchanged more frequently than recommended when the

sample reception mode is selected for 8 hours. / Les tubes de robinet à manchon doivent

être remplacés plus souvent que la fréquence recommandée lorsque le mode de réception

d'échantillons choisi est de 8 heures.

Isoline 2CR6 Defibrillation Leads Sorin CRM S.R. L. 2011-11-14 2011-10-20 67993 Type II 2CR-6 S2CR605346, S2CR605347 A batch of Isoline Defibrillation Leads was labelled with an incorrect use before date (UBD),

which was greater than the maximum of 36 months shelf life. The date printed on the labels

was 5 May 2013, while the correct UBD is 21 September 2012. / Les étiquettes d'un lot de

sondes de défibrillation Isoline portaient une date de péremption erronée, qui dépassait la

durée de conservation de 36 mois. La date imprimée sur les étiquettes était le 5 mai 2013,

alors que la date de péremption aurait dû être le 21 septembre 2012.

A) Painsmart IOD (Ambulatory Infusion Pump)

B) 6000 CMS (Ambulatory Infusion Pump)

C) 4000 CMS (Ambulatory Infusion Pump)

Zevex Inc. Also trading as Moog Medical Devices Group 2011-11-14 2011-04-04 62624 Type I A) 360-1200, 360-1300, 360-1300P

B) 360-1100, 360-1400

C) 350-1000, 350-1100, 350-1200


> 10 Numéros, Contactez Fabriquant



C) >10 Numbers, Contact Manufacturer,


Accuracy of infusion with a syringe varies widely depending on the medication and stiction

between the barrel and plunger of individual syringes. The effects of the variables have

made the accuracy difficult to evaluate as each condition produces differing effects from the

syringe variables. Therefore, Zevex is not confident in providing accuracy percentages for

syringes as they may be misleading if the application conditions are also considered. As a

result, the labeling will be modified to indicate the accuracy of delivery from a syringe

cannot be guaranteed. / La précision de l'infusion au moyen d'une seringue varie

considérablement en fonction du médicament et du frottement entre le corps et le piston de

seringues individuelles. Les effets des variables ont rendu la précision difficile à évaluer

puisque chaque type de condition produitdivers effets selon les variables de la seringue.

Pour cette raison. Zevex préfère ne pas fournir de pourcentages de précision pour les

seringues, car ils peuvent induire en erreur si l'on prend en compte les conditions de

l'application. En conséquence, l'étiquetage sera modifié de manière à indiquer que la

précision d'administration d'une seringue ne peut pas être garantie.

A) Brilliance ICT System - System

B) Brilliance ICT SP System - Main

Philips Medical Systems (Cleveland) Inc. 2011-11-14 2011-10-13 67753 Type III A) 728306

B) 728311

A) N/A

B) N/A

The Common Image Reconstruction System (CIRS) encounters an error and requires

reboot of the system. Raw data that has been previously acquired will not be lost. / Le

système de reconstruction d'image affiche un message d'erreur et doit être redémarré. Les

données brutes acquises précédemment ne seront pas perdues.

QuickShield with Snappy Safety Holder Greiner Bio One GMBH 2011-11-14 2011-08-11 67933 Type II 450254 B041104, B011101, B051105, B071106,

B071004, B071005, B081006, B121009,

B011102, B021103

Some of the Vacuette Quickshield with snappy safety holder have a crack at the hub, which

could cause the threaded neck that holds the needle to break off and expose the needle. /

Certains des Quickshield with snappy safety holder Vacuette présentent une fissure au

niveau du raccord, ce qui pourrait faire en sorte que le collet fileté qui retient l'aiguille se

brise et expose ainsi l'aiguille.

Revolution XRD X-Ray Systems GE Medical Systems, LLC 2011-11-14 2011-10-24 67286 Type II 2259988-2, 2351505 N/A GE Healthcare has become aware of a potential issue associated with the hand grip that is

clamped to the table top of your Revolution XR/D X-ray systems that may impact patient

safety. The hand grip accessory that is clamped to the table top may not be properly

adjusted and can dislodge during use. Should this happen during patient loading or

unloading, patient injury could occur. / GE Healthcare a constaté qu'il existe un problème

possible associé à la poignée se trouvant sur la table de vos systèmes de radiographie X

Revolution XR/D et que ce problème peut nuire à la sécurité des patients. La poignée

pourrait ne pas être bien fixée et elle pourrait se détacher au cours de l'utilisation du

système. Si la poignée se détache alors que des patients embarquent sur le système ou en

débarquent, ces derniers pourraient être blessés.

Nexgen CKS Prolong-LPS Mobile Articular Zimmer Inc. 2011-11-14 2011-10-19 68044 Type II 00594703012, 00594706012 61732058, 61732066 Zimmer has initiated a recall of the nexgen complete knee solution Prolong LPS-Mobile

Articular Surface because of a device packaging mix-up. The packaging is labeled as a 00-

5947-030-12 size c 12mm height use with plate 2,3,4 but contains a 00-5947-060-12 size F

12mm height use with plate 5,6,6 Articular Surface and vice versa. / Zimmer a émis un

rappel pour la solution de genou complète Nexgen Prolong LPS-Mobile Articular Surface,

en raison d'un mélange d'emballage des dispositifs. Il est indiqué ce qui suit sur l'emballage:

«00-5947-030-12, taille c, 12 mm de hauteur, utiliser avec les plateaux 2,3,4», mais il

devrait plutôt être indiqué ce qui suit: «00-5947-060-12, taille F, 12 mm de hauteur, utiliser

avec les plateaux 5,6,6 Articular Surface» et vice versa.

Complement Control Cells Immucor Inc. 2011-11-14 2011-10-20 68281 Type II 7930 34161 Weakened reactivity and negative results when using Lot 34161 of the product. / Réactivité

plus faible et résultats négatifs lorsqu'on utilise le lot 34161 du produit.

NM Application Suite Philips Medical Systems (Cleveland) Inc. 2011-11-14 2011-10-12 67756 Type II 453560477471 N/A Philips has become aware of an issue that may be encountered when completing a specific

workflow which may result in the system providing inaccurate ejection fraction information. /

Philips a constaté qu'un problème peut être rencontré lors de l'accomplissement de tâches

spécifiques, ce qui peut faire en sorte que le système fournisse des données de fraction

d'éjection incorrectes.

A) Hitachi LDL-Cholesterol, No Pretreatment, LDL-C Plus 2nd

GEN

B) Hitachi LDL-C Plus

C) Cobas C111 LDL-Cholesterol (LDL_C)


B) 04711220190, 04714423190

C) 05401682190

A) 630746-01, 637097-01, 644941-01

B) 630737-01, 637092-01, 644936-01, 630787-

01, 637065-01, 644933-01

C) 630749-01, 637101-01, 644944-01

Internal investigation revealed the instability of an enzyme in RL which is used to suppress

the ascorbic acid interference. / Une enquête interne a révélé l'instabilité d'un enzyme dans

le RL utilisé pour supprimer

l'interférence d'acide ascorbique.

A) Kinematic II Rotating Hinge Total Knee System

B) HowMedica Modular Resection System - Proximal Tibia

C) Souter Strathclyde Elbow Prothesis Ulnar Component

D) Modular Replacement System - Kinematic Rotating Hinge

KN Met Tib Insert

E) Modular Replacement Sytem - Kinematic Knee All Poly

Tibial Plug

F) Eius Knee System - Tibial Components

G) Modular Rotating Hinge Knee System - Femoral

Components

H) Modular Rotating Hinge Knee System - Tibial Inserts /

Components/ Sleeve

I) Modular Rotating Hinge Knee System - Bumpr Insert / Axle

J) Kinematic II - Duration Poly Dome Patella with 3 Pegs

K) Avon Patello-Femoral Joint - Patella Component

L) Duracon ISA Mobile Bearing Knee Tibial Insert

M) Global Modular Replacement System - Bushing

N) Global Modular Replacement System - Proximal Tibial

Insert

O) Kinemax Plus Total Knee System - Stabilizer Tibial

Components

P) Kinemax Plus Total Knee System - Patellar Components

Q) Kinemax Plus Total Knee System - Condylar Tibial

Components

R) Duracon Total Knee System - CS Lipped Tibial Insert

S) Kinematic II Modular Condylar Tibila Inserts

HowMedica Osteonics Corporation 2011-11-14 2011-09-06 67002 Type II A) 6485-4-100 / B) 6465-6-007, 6465-6-018, 6466-4-308, 6466-9-100, 6466-9-200, 6466-9-240, 6466-9-

245, 6466-9-306 / C) 6944-1-120, 6944-2-220 / D) 6485-2-008, 6485-2-011, 6485-2-016, 6485-2-021, 6485-

2-108, 6485-2-111, 6485-2-116, 6485-2-121, 6485-2-208, 6485-2-211, 6485-2-216, 6485-2-221, 6485-2-

308, 6485-2-311, 6485-2-316, 6485-2-321, 6485-2-408, 6485-2-411, 6485-2-416, 6485-2-421, 6485-2-460,

6485-2-465, 6485-2-508, 6485-2-511, 6485-2-608, 6485-2-611, 6485-4-111, 6485-4-113, 6485-4-116,

6485-4-121, 6485-4-211, 6485-4-213, 6485-4-216, 6485-4-221 / E) N/A / F) 6636-2-308, 6636-2-309, 6636-

2-310, 6636-2-312, 6636-2-318, 6636-2-319, 6636-2-320, 6636-2-322, 6636-2-408, 6636-2-409, 6636-2-

410, 6636-2-412, 6636-2-418, 6636-2-419, 6636-2-420, 6636-2-422, 6636-2-508, 6636-2-509, 6636-2-510,

6636-2-512, 6636-2-518, 6636-2-519, 6636-2-520, 6636-2-522, 6636-2-608, 6636-2-609, 6636-2-610,

6636-2-612, 6636-2-618, 6636-2-619, 6636-2-620, 6636-2-622, 6636-2-708, 6636-2-709, 6636-2-710,

6636-2-712, 6636-2-718, 6636-2-719, 6636-2-720, 6636-2-722. / G) 6481-2-150 / H) 6481-2-140, 6481-3-

210, 6481-3-213, 6481-3-216, 6481-3-220, 6481-3-224, 6481-3-310, 6481-3-313, 6481-3-316, 6481-3-320,

6481-3-324 / I) 6481-2-110, 6481-2-130, 6481-2-133 / J) 6485-1-915, 6485-3-915, 6485-5-915 / K) 6430-

0-020, 6430-0-030, 6430-0-040 / L) 6642-2-009, 6642-2-011, 6642-2-013, 6642-2-016, 6642-2-209, 6642-2-

211, 6642-2-213, 6642-2-216, 6642-2-409, 6642-2-411, 6642-2-413, 6642-2-416, 6642-2-609, 6642-2-611,

6642-2-613, 6642-2-616, 6642-3-009, 6642-3-011, 6642-3-013, 6642-3-016, 6642-3-209, 6642-3-211,

6642-3-213, 6642-3-216, 6642-3-409, 6642-3-411, 6642-3-413, 6642-3-416, 6642-3-609, 6642-3-611,

6642-3-613, 6642-3-616 / M) 6495-2-105

N) 6495-3-010, 6495-3-013, 6495-3-016, 6495-3-020, 6495-3-024 / O) 6479-5-508, 6479-5-510, 6479-5-

512, 6479-5-515, 6479-5-518, 6479-5-608, 6479-5-610, 6479-5-612, 6479-5-615, 6479-5-618, 6479-5-621,

6479-5-708, 6479-5-710, 6479-5-712, 6479-5-715, 6479-5-718, 6479-5-721, 6479-5-725, 6479-5-808,

6479-5-810, 6479-5-812, 6479-5-815, 6479-5-818, 6479-5-821, 6479-5-908, 6479-5-910, 6479-5-912,

6479-5-915, 6479-5-918, 6479-5-921, 6479-5-925 / P) 6479-4-900, 6479-4-911, 6479-4-920 / Q) 6479-5-

008, 6479-5-010, 6479-5-012, 6479-5-015, 6479-5-018, 6479-5-021, 6479-5-025, 6479-5-108, 6479-5-110,

6479-5-112, 6479-5-115, 6479-5-118, 6479-5-121, 6479-5-125, 6479-5-208, 6479-5-210, 6479-5-212,

6479-5-215, 6479-5-218, 6479-5-221, 6479-5-225, 6479-5-308, 6479-5-310, 6479-5-312, 6479-5-315,

6479-5-318, 6479-5-321, 6479-5-325, 6479-5-408, 6479-5-410, 6479-5-412, 6479-5-415, 6479-5-418,

6479-5-421, 6479-5-425 R) N/A / S) 6471-0-808, 6471-0-811, 6471-0-813, 6471-0-816, 6471-3-808, 6471-

3-811, 6471-3-813, 6471-3-816, 6471-5-808, 6471-5-811, 6471-5-813, 6471-5-816

A) All / Tous

B) All / Tous

C) All / Tous

D) All / Tous

E) All / Tous

F) All / Tous

G) All / Tous

H) All / Tous

I) All / Tous

J) All / Tous

K) All / Tous

L) All / Tous

M) All / Tous

N) All / Tous

O) All / Tous

P) All / Tous

Q) All / Tous

R) All / Tous

S) All / Tous

A packaging discrepancy was identified in specific Lots of Stryker's Duration packaging. It

was found that the outer blister container did not meet Stryker's internal packaging

specifications: Specifically, seal width and/or breach of the outer seal. Each potentially

affected duration packaging unit includes an inner and outer blister container. The inner

blister was found intact, and product sterility was not ompromised. / On a remarqué la

présence d'une anomalie dans un lot spécifique d'emballages Duration de Stryker. On a

constaté que l'emballage coque extérieur n'était pas conforme aux spécifications

d'emballage intérieur de Stryker, relativement à la largeur du joint et/ou à une perforation du

joint extérieur. Chaque emballage Duration possiblement compromis comprend des

emballages coques extérieur et intérieur. L'emballage coque intérieur était intact et la

stérilité du produit n'a pas été compromise.

Shoulderflex Massager King International: An Innovative Health & Wellness Products

Company

2011-11-14 2011-08-30 Type II 67022 N/A N/A Recall of Shoulderflex due to one death and one near-strangulation (not in Canada). Users

are recommended to destroy the device as per manufacturer's instructions. / Rappel de

Shoulderflex en raison d'un décès etd'un incident d'étouffement évité (en dehors du

Canada). On recommande aux utilisateurs de détruire ce dispositif conformément aux

instructions du fabricant.

I-Stat 1 Analyzer System - CTNI Cartridge, Controls and

Calibrators

Abbott Point of Care Inc. 2011-11-14 2011-09-30 Type III 67584 06F15-03 > 10 Numbers Contact Manufacturer,

> 10 Numéros, Contactex Fabriquant

Abbott Point of Care Inc. (APOC) has determined that lots of I-Stat CTNI cartridges

beginning with the letter "T" may exhibit a higher than expected variability in reported

results. All other CTNI lots are unaffected by this issue. This increased variability may

result in falsely elevated or falsely depressed results. / Abbott Point of Care Inc. (APOC) a

constaté que les lots de I-Stat CTNI cartridges débutant par la lettre T peuvent présenter

une variabilité des résultats plus élevée que prévue. Tous les autres lots de CTNI ne sont

pas touchés par ce problème. Cette variabilité plus élevée peut entraîner des résultats

faussement élevés ou bas.

Architect System - Urea Nitrogen Assay Abbott Laboratories Diagnostic Division 2011-11-14 2011-10-07 Type III 67588 7D75-21, 7D75-31 97642UN11, 97668UN11 Abbott Diagnostics is recalling Clinical Chemistry Urea Nitrogen Reagent lots 97642UN11 &

97668UN11 due to particulate matter in some reagent cartridges. The particulate matter

has been identified as an aureobasidium species which alone does not represent a hazard,

but generates visible matter within the reagent cartridge, and may cause discoloration over

time. / Abbott Diagnostics a émis un rappel pour les lots 97642UN11 et 97668UN11 de

réactifs d'azote uréique de chimie clinique en raison de la présence de matières

particulaires danscertaines cartouches de réactifs. Les matières particulaires ont été

identifiées comme étant une espèce d'aureobasidium qui ne représente pas, par elle-même,

un danger, mais qui produit des matières visibles dans une cartouche de réactif et peut

causer une décoloration au fil du temps.

A) Cryomatic System - Retinal Probe

B) Cryomatic System - Intra Vitreal Probe

C) Cryomatic System - Curved Cataract Probe

D) Cryomatic System - Collins Trichiasis

Keeler Limited 2011-11-14 2011-08-12 Type III 67622 A) 2509-P-8000, 2509-P-8001, 2509-P-8002

B) 2509-P-8003

C) 2509-P-8004

D) 2509-P-8006

A) N/A

B) N/A

C) N/A

D) N/A

Wrong issue of user instruction supplied with probes, as a consequences the incorrect

method of sterilization may be used. / On a fourni la mauvaise version des instructions avec

la sonde. Par conséquent, on pourrait

utiliser la mauvaise méthode de stérilisation.

Architect "I" System - Cyclosporine Assay Abbott Laboratories Diagnostic Division 2011-11-14 2011-10-14 Type II 67747 1L75-01, 1L75-25, 1L75-55 > 10 Numbers Contact Manufacturer,

> 10 Numéros, Contactex Fabriquant

Abbott has confirmed that the ARCHITECT Cyclosporine assay has the potential to

generate falsely elevated or depressed results with patient samples due to precision

exceeding the Package Insert claim of <15% total CV. Calibrators and Controls also have

the potential to be impacted by the assay imprecision. Abbott has determined that the

imprecision is due to an interaction between the ARCHITECT Cyclosporine assay and the

resin used to produce certain ARCHITECT Reaction Vessel (RV) lots. Assay precision can

be impacted if RV lots containing different resin are mixed in the ARCHITECT hopper and

used to test ARCHITECT Cyclosporine. At this time, there is no data that indicates there is

impact to other ARCHITECT assays. We are continuing to investigate this issue.

Abbott M2000 System - M2000SP Instrument Abbott Molecular Inc. 2011-11-14 2011-10-14 Type II 67764 9K14-01, 9K14-02 N/A There have been two reported instances in which the liquid waste sensor and components in

the M2000SP lower instrument cabinet overheated or caught fire. In both cases the event

was contained within the lower cabinet of the M2000SP. There were no injuries. / On a

signalé deux incidents lors desquels le capteur de déchets liquides et les composants de

l'armoire inférieure de l'instrument M2000SP ont surchauffé ou ont pris feu. Dans les deux

cas, l'incident a été limité à l'armoire inférieure de l'instrument M2000SP. Il n'y a eu aucun

blessé.

Slidex Pneumo Kit bioMerieux SA 2011-11-14 2011-10-06 Type II 67824 58821 1101103874 An equivocal results obtained with the strain Streptococcus Pyogenes ATCC 19615 and the

R1 Reagent (Anti-Streptpcoccus Pneumoniae Latex) indicates a deterioration of the

reagent. In this case, these reagents can not be used. / Les résultats équivoques obtenus à

l'aide de la souche ATCC 19615 de la bactérie Streptococcus Pyogenes et du réactif R1

(Anti-Streptpcoccus Pneumoniae Latex) indiquent une détérioration du réactif. Dans ce cas,

ces réactifs ne peuvent pas être utilisés.

A) 1 mL BDT Oral Syringe with tip cap, amber

B) 1 mL BDT Oral Syringe with tip cap, clear

C) 3 mL BDT Oral Syringe with tip cap, amber

D) 3 mL BDT Oral Syringe with tip cap, clear

E) 5 mL BDT Oral Syringe with tip cap, amber

F) 5 mL BDT Oral Syringe with tip cap, clear

G) 10 mL BDT Oral Syringe with tip cap, amber

H) 10 mL BDT Oral Syringe with tip cap, clear

Becton Dickinson and Company 2011-11-14 2011-10-06 Type III 67964 A) 305207

B) 305217

C) 305210

D) 305220

E) 305220

F) 305218

G) 305209

H) 305219

A) 0296609, 0323224, 0323225, 1003684,

1027148, 1052674

B) 0267425, 0267426, 1027168

C) 0294726, 0323228, 1052682

D) 1052683

E) 0294731, 1003692, 1027154

F) 0296605, 0323230, 0323231, 1003683,

1027175, 1042244

G) 1003693, 1027159

H) 0240048, 0296614, 1003672, 1027179,

1052688

Beckton Dickinson has received reports that the oral syringe tip caps may come loose from

the syringe, potentially resulting in leakage of medication from the syringe. / Beckton

Dickinson a reçu des rapports selon lesquels les embouts des seringues orales pourraient se

détacher de la seringue, ce qui pourrait faire en sorte que le médicament coule hors de la

seringue.

A) Vitek 2 Compact 30 System

B) Vitek 2 Compact 60 System

C) Vitek 2 Instrument

D) Vitek 2 XL Instrument

bioMerieux Inc. 2011-11-14 2011-10-19 Type III 68240 A) W0452

B) W0452

C) W0452

D) W0452

A) >10 Numbers Contact Manufacturer,

>10 Numéros, Contactex Fabriquant

B) >10 Numbers Contact Manufacturer,


C) >10 Numbers Contact Manufacturer,


D) >10 Numbers Contact Manufacturer,


Incorrect version of the English language Vitek 2 Systems Software User Manual dated

03/2010 was inadvertently installed on the hard drives of some new and refurburbished

computers containing Vitek 2 Systems Software Version 5.01 / La mauvaise version du

manuel anglais de l'utilisateur du logiciel de systèmes Vitek 2, daté du 03/2010, a été

installée sur les disques durs de certains ordinateurs neufs et remis en état munis de la

version 5.01 du logiciel de systèmes Vitek 2.

Cobas C111 with ISE Stand Alone Configuration Roche Diagnostics Ltd. 2011-11-14 2011-10-18 Type II 68296 4777433001 N/A The manufacturer received complaints reporting that on result printouts, one or more

numbers or caracters can be missing. It has been observed that the printer may skip leading

blanks which may result in a wrong printing layout. The missing numbers or characters can

affect every kind of printout like results, measurement units or other text. / Le fabricant a

reçu des plaintes selon lesquelles un ou plusieurs chiffres ou caractères pourraient être

manquants sur les copies papier des résultats. On a constaté que l'imprimante peut sauter

les espaces à gauche, ce qui peut causer des erreurs lors de l'impression. Les chiffres ou

caractères manquants peuvent avoir une incidence sur tous les types d'imprimés, comme

des résultats, des unités de mesure ou d'autre texte.

Illumena 150ml Linden Luer and Regular Luer Syringes with

Handi-Fil Straw

Liebel-Flarsheim Company 2011-11-14 2011-10-26 Type III 68378 900101, 900103 >10 Numbers Contact Manufacturer,


Certain lot numbers of the individual syringe packages labelled to contain the Illumina

150ml Linden Luer Syringe with Handi-Fil Straw, catalogue number 900103, may contained

the similar product, the Illumena 150ml Regular Luer Syringe with Handi-Fil Straw,

catalogue number 900101. / Certains numéros de lots d'emballages de seringues

individuelles dont l'étiquette mentionne que l'emballage contient la seringue Illumina 150 ml

Linden Luer à Handi-Fil Straw, numéro de catalogue 900103, pourraient en fait contenir un

produit semblable, la seringue Illumena 150 ml Regular Luer à Handi-Fil Straw, numéro de

catalogue 900101.

Slidex Staph Plus bioMerieux SA 2011-11-14 2011-10-25 Type II 68387 73115, 73116 >10 Numbers Contact Manufacturer,


A problem has been confirmed the Slidex Staph Plus Reagent which could lead to false

positive results with S.Non-Aureus strains. BioMerieux have not been able to resolve the

issue and decided to temporarily suspend production and sale of new batches of Slidex

Staph Plus. / On a confirmé la présence d'un problème avec le réactif Slidex Staph Plus qui

pourrait entraîner des résultats faussement positifs avec les souches S.Non-Attreus.

BioMerieux n'a pas été en mesure de résoudre le problème et a donc décidé d'arrêter la

production temporairement et de vendre un nouveau lot de Slidex Staph Plus.

Cobas Ampliprep Sample Tubes Roche Diagnostics Ltd. 2011-11-14 2011-10-21 Type III 68298 3137040001 11500503, 11504503, 11510503, 11513503,

11515503

Certain lots of the Cobas Ampliprep instrument, samples input barcode clips may have

irregular inner surfaces which can cause the sample input tubes to remain lodged in the

barcode clips. / Les clips de code à barres d'entrée d'échantillons de certains lots

d'instrument Cobas Ampliprep pourraient présenter des surfaces intérieures irrégulières, ce

qui pourrait faire en sorte que les tubes d'entrée d'échantillons demeurent coincés dans les

clips de code à barres.

A) Soft Reline Kits (Both Heat and Self Cure)

B) Self Cure Repair Acrylic

C) Heat Cure Denture Acrylic

D) Tooth Acrylics

E) Silver and Gold post solder

F) Super Bonding Kit

G) UBAR Kit (Metal Bonding Acrylic)

Protech Professional Products Inc. 2011-11-28 2011-10-11 66738 Type II A) Starting with LR, Starting with RL

B) Starting with PLU

C) Starting with PDA

D) RUC59, RUC%(A, RUC59A!, RUC59LB, RUC61, RUC61A, RUC61A1,

RUC61LB, RUC62, RUC62A1, RUC62LB, RUC65, RUC65A, RUC65A1,

RUC65LB, RUC66, RUC66A, RUC66A1, RUC66LB, RUC67, RUC67A, RUC67A1,

RUC67LB, RUC69, RUC69A, RUC69A1, RUC69LB, RUC77, RUC77A, RUC77A1,

RUC77LB, RUC81, RUC81A, RUC81A1, RUC81LB, RUC85, RUC85A, RUCA1,

RUC85LB, RUC87, RUC87A, RUC87A1, RUC87LB, RUCBW, RUCDI, RUCDIA,

RUCDIA1, RUCDILB, RUCLI, RUCLIA, RUCLILB, RUCOW, RUCOWA,

RUCOWA1, RUCOWOLB, RUCPO,RUCPOA, RUCPOA1, RUCPOLB, RUCUW,

RUCUWA1

E) CSS1, CSS3, GDS1, GDS3

F) SBA11, SBA12, SBL12, SBT12

G) RUCVPG, Starting with RUC11, Starting with RUCV11

A) N/A

B) N/A

C) N/A

D) N/A

E) N/A

F) N/A

G) N/A

Products are not licensed.

LABScreen Product-LABScreen MICA Single Antigen -Group 1 One Lambda Inc 2011-11-28 2011-07-18 66894 Type III N/A LSMICA001-002, LSMICA001-003, LSMICA001-

004

A false reaction maybe observed with the Mica019 antigen. Upon investigation, trnsfected

Mica019 cell lines (RC1223) demonstrated a lack of or presence of recombinant Mica019

inserts.

Penlon Crystal Laryngoscope Blades Penlon Limited 2011-11-28 2011-09-21 67582 Type II 50674, 50675 All / Tous Penlon has been made aware of an incident where Mac 3 blades have been incorrectly

packaged in disposable bags labelled as Mac 4 and then packed in a carton stating size

Mac 4.

Cervicore Chisel Guide Stryker Spine SAS 2011-11-28 2011-10-07 67587 Type II 48290110 07G781 Stryker Spine was aware that there is a possible inability to insert the Cervicore Chisel guide

over the fixation pin. It was discovered that the hole was too narrow to accommodate the

fixation pin.

A) ZMR Hip System Taper Stems

B) ZMR Hip System Spout Body

C) ZMR Hip System Cone Body

D) ZMR Hip System Calcar Body

E) ZMR Hip System Splined Stems

F) ZMR Hip System Porous Stems

G) ZMR Hip System Spout AA Body

H) ZMR Hip System Cone AA Body

I) ZMR Hip System Calcar AA Body

J) ZMR Hip System Porous Stems, Line Ext.

K) ZMR Hip SystemSlotted Porous Bow. Stem

Zimmer Inc. 2011-11-28 2011-10-25 68351 Type I A) 00-9982-014-13, 00-9982-014-18, 00-9982-015-13, 00-9982-015-18, 00-9982-016-13, 00-9982-016-18,

00-9982-016-23, 00-9982-017-13, 00-9982-017-18, 00-9982-017-23, 00-9982-018-13, 00-9982-018-18, 00-

9982-018-23, 00-9982-019-13, 00-9982-019-18, 00-9982-019-23, 00-9982-020-18, 00-9982-020-23, 00-

9982-022-18, 00-9982-022-23 / B) 00-9990-017-40, 00-9990-017-46, 00-9990-018-40, 00-9990-018-46, 00-

9990-019-40, 00-9990-019-46, 00-9990-020-40, 00-9990-020-46, 00-9990-021-40, 00-9990-021-46, 00-

9990-023-40, 00-9990-023-46, 00-9991-017-45, 00-9991-017-55, 00-9991-018-45, 00-9991-018-55, 00-

9991-017-45, 00-9991-019-45, 00-9991-019-55, 00-9991-020-45, 00-9991-020-55, 00-9991-021-45, 00-

9991-021-55, 00-9991-023-45, 00-9991-023-55, 00-9997-017-45, 00-9997-017-55, 00-9997-018-45, 00-

9997-018-55, 00-9997-019-45, 00-9997-019-55 / C) 00-9993-017-35, 00-9993-017-45, 00-9993-017-55, 00-

9993-018-35, 00-9993-018-45, 00-9993-018-55, 00-9993-019-35, 00-9993-019-45, 00-9993-019-55, 00-

9993-020-35, 00-9993-020-45, 00-9993-020-55, 00-9993-021-35, 00-9993-021-45, 00-9993-021-55, 00-

9993-023-35, 00-9993-023-45, 00-9993-023-55, 00-9996-017-35, 00-9996-017-45, 00-9996-017-55, 00-

9996-018-35, 00-9996-018-45, 00-9996-018-55, 00-9996-019-35, 00-9996-019-45, 00-9996-019-55, 00-

9996-020-35, 00-9996-021-35, 00-9996-023-35 / D) 00-9994-017-45, 00-9994-017-55, 00-9994-018-45, 00-

9994-018-55, 00-9994-019-45, 00-9994-019-55, 00-9994-020-45, 00-9994-020-55, 00-9994-021-45, 00-

9994-021-55, 00-9994-023-45, 00-9994-023-55, 00-9998-017-35, 00-9998-017-45, 00-9998-017-55, 00-

9998-018-35-00-9998-018-45, 00-9998-018-55, 00-9998-019-35, 00-9998-019-45, 00-9998-019-55 / E) 00-

9980-120-21, 00-9980-120-22, 00-9980-120-32, 00-9980-135-21, 00-9980-135-22, 00-9980-135-32, 00-

9980-135-33, 00-9980-150-21, 00-9980-150-22, 00-9980-150-32, 00-9980-150-33, 00-9980-165-21, 00-

9980-165-22, 00-9980-165-32, 00-9980-165-33, 00-9980-180-21, 00-9980-180-22, 00-9980-180-32, 00-

9980-180-33, 00-9980-195-21, 00-9980-195-22, 00-9980-195-32, 00-9980-195-33, 00-9980-210-22, 00-

9980-210-22, 00-9980-210-32, 00-9980-210-33, 00-9980-225-22, 00-9980-225-32, 00-9980-225-33, 00-

9980-240-22, 00-9980-240-32, 00-9980-240-33, 00-9980-255-22, 00-9980-255-32, 00-9980-255-33 / F) 00-

9981-120-21, 00-9981-120-22, 00-9981-120-32, 00-9981-135-21, 00-9981-135-22, 00-9981-135-32, 00-

9981-135-33, 00-9981-150-21, 00-9981-150-22, 00-9981-150-32, 00-9981-150-33, 00-9981-165-21, 00-

9981-165-22, 00-9981-165-32, 00-9981-165-33, 00-9981-180-21, 00-9981-180-22, 00-9981-180-32, 00-

9981-180-33, 00-9981-195-21, 00-9981-195-22, 00-9981-195-32, 00-9981-195-33, 00-9981-210-33, 00-

9981-225-33 / G) 00-9940-016-36, 00-9940-016-40, 00-9990-016-36, 00-9990-016-40 / H) 00-9941-016-

35, 00-9942-016-35, 00-9943-016-35, 00-9996-016-35 / I) 00-9946-016-35, 00-9947-016-35, 00-9948-016-

35, 00-9998-016-35 / J) 00-9981-210-22, 00-9981-210-32, 00-9981-225-22, 00-9981-225-32, 00-9981-240-

22, 00-9981-240-32, 00-9981-240-33, 00-9981-255-22, 00-9981-255-32, 00-9981-255-33 / K) 00-9983-120-

32, 00-9983-135-32, 00-9983-135-33, 00-9983-150-32, 00-9983-150-33, 00-9983-150-34, 00-9983-165-32,

00-9983-165-33, 00-9983-165-34,00-9983-180-32, 00-9983-180-33, 00-9983-180-34, 00-9983-195-32, 00-

9983-195-33, 00-9983-195-34, 00-9983-210-32, 00-9983-210-33, 00-9983-210-34, 00-9983-225-323, 00-

9983-225-33, 00-9983-225-34, 00-9983-240-32, 00-9983-240-33, 00-9983-240-34, 00-9983-255-32, 00-

9983-255-33, 00-9983-255-34

A)All

B)All

C)All

D)All

E)All

F)All

G)All

H)All

I)All

J)All

K)All

This action is being conducted for a labeling correction of the ZMR Porous Revision Hip

Prosthesis and ZMR Revision Taper Hip Prosthesis, including the indications for use,

contraindications, and warnings. Investigation has shown the potential for fracture of the

ZMR Revision Hip System where bone quality and bone quantity (especially in the proximal

location) and resultant proximal support is not optimal. The device indication will now be

limited to cementless revision hip arthroplasty.

Cobas 4000 - Cobas C311 (stand alone configuration) Roche Diagnostics GMBH 2011-11-28 2011-10-24 68254 Type II 4826876001 All the Software Versions The manufacturer has identified during internal investigation, a software malfunction on the

Cobas 4000/Cobas C311 Analyzer that could potentially lead to incorrect ISE test

measurements.

OBSERVA Database Management System bioMérieux Inc. 2011-11-28 2011-10-12 68288 Type III 218039, 248027, 248029, 248035, 248036, 248043, 248055, 248056, 410461,

410462

N/A An anomaly with all versions of Observa has been identified that can cause positive and

negative accessions to not be sent to the bottle lis. This anomaly can occur when results are

received from the Bact/Alert 3D when Observa is running a scheduled bottle LIS link

transmission and where the bottle LIS connection has been configured to send new test

results.

Triathlon Slap Hammer Howmedica Osteonics Corporation 2011-11-28 2011-10-13 67749 Type II 6541-4-803 CRZW01 Complaints were received with regard to disfiguration of the plastic under-mold of the

Triathlon Slap Hammer.

CareFusion Avea Ventillators CareFusion 2011-11-28 2011-10-07 67761 Type II Avea > 100 Numbers, Contact Manufacturer Affected Avea Ventilators can over time develop a failure where the ventilator activates a

false extended HIHG Ppeak alarm, opens the safety valve and stops ventilating. While the

extended high Ppeak alarm is activated, by design, the safety valve OPS to ambienta air

and allowing spontaneous breathing patients to continue breathing. Despite activation of the

alarm under these circumstances, the paitent is not subjected to elevated airway pressures.

A) Biomet Arcom Patella Components

B) Biomet Arcom Patella Components

Biomet Orthopaedics 2011-11-06 2011-10-06 67768 Type II A) 184700, 184720, 184722

B) 184762, 184780, 184782

A) 190350, 079520, 248190, 506170, 344670,

423400, 079530

B) 432450, 438780, 527760, 190440, 498310

Labelling error identified on the external packaging of sizes 25 mm and 28 mm patella

buttons indicating the devices as "for use with the Vanguard, Maxim, Ascent and AGC Knee

System". These devices are not for use with the AGC Knee System.

Ambi Compression Hip Screw System - Standard Barrel Plates Smith & Nephew, Inc. 2011-11-28 2011-10-19 68305 Type II 12-1130 10KT46884A The 130 degree plate was marked incorrectly as 135 degree

Trilogy 200 Respironics Inc. 2011-11-28 2011-10-11 68381 Type II CA1032800 TV211032405, TV211032409, TV211032412,

TV211032413, TV211032414, RV211032415,

TV211032419, TV211032420, TV211032430,

TV211032431

A small quantity of devices do not meet the minimum press-force required for assembling

the impeller onto the motor shaft of the blower unit. The unit may be noisy or this may

impact therapy up to the point of generating a device alarm or in the worst case could result

in a blower failure causing the device to stop delivering therapy

Anchorlok Soft Tissue Anchor System Wright Medical Technology Inc. 2011-11-28 2011-11-03 68581 Type II 5100-0002, 5100-0004, 5100-0006, 5100-0008, 5100-0010, 5100-0012, 5100-

0014, 5100-0016, 5100-0018

> 100 Numbers, Contact Manufacturer Wright Medical Technology has become aware of an issue relating to a label discrepancy

that affects the shelf-life listed on the current Anchorlok Soft Tissue Anchor. The product

functions as intended, however there is not adequate justification on file to support the 8

year packaging shelf life listed on the current label.

Cerner ProVision Document Imaging Cerner Corp. 2011-11-28 2011-09-14 67343 Type II N/A Imaging 2007.18 35863,

Imaging 2007.09 38896,

Imaging 2010.01 41919,

Imaging 2010.02 45389

This issue occurs because an older version of a non-clinical document can be displayed

instead of the most recent version. Typically, the system displays the most recent version,

and the user can select to view older versions from the history window. However, an older

version of the document is displayed automatically when you do not select the older version

or are aware that a newer version exists.

Blood Administration Set Fenwal, Inc. 2011-11-28 2011-10-07 67763 Type II 4C2223 > 10 Numbers, Contact Manufacturer There is a labelling issue with the 4C2223 Blood Component Infustion Set in which the

package label incorrectly states 80 micron filter when the actual filter is a standard blood

filter of 170-260 micons in size.

Symbiq Infuser Hospira Inc. 2011-11-28 2011-10-17 68256 Type II 16026, 16027 N/A In instances where the pump alarms for accumulated air in line and detects froth in quick

sucession, the infusion will stop as desired, but a malfunction might occur where the pump

will stop operating.

Advia Centaur XP HUV AG/AB Combo (Chiv) Assay Siemens Healthcare Diagnostics Inc. 2011-11-28 2011-10-28 68460 Type III 6520528 20 Product from Lot 020 is not authorized for sale in Canada and was accidentally sent to

customers. Customers should have received Lot 018.

Luxtec Ultralite Pro Headlight Integra Burlington MA, Inc. 2011-11-28 2011-10-14 67766 Type III N/A AX2000BIF, AX2100BIF, AX1375BIF,

AX1385BIF, 1380LX, 1328

The design of the Ultralite Mark II model relies on the cable adapter that is is assembled

through the headlight body top into the lens cell top, to hold the headlight in place and

prevent the headlight from falling off. If the cable adapter becomes loose there is a

potential that the headlight assembly can become separated from the headband assembly

and drop into the patient wound site.

Catheterization Table Toshiba Medical Systems Corporation 2011-11-28 2011-10-01 68228 Type II CAT-850B > 10 Numbers, Contact Manufacturer During the patient transfer from a stretcher to the catheterization table, unexpected tabletop

rotation occurs if the tabletop is not positioned in its foot-end, or there is not enough

assistance while transferring the patient to the catheterization table. When excessive force

is added to the tabletop, it may rotate unexpectedly.

VITROS Chemistry Products DT Calibrator Kit Ortho-Clinical Diagnostics Inc. 2011-11-28 2011-10-14 68304 Type III N/A 37, 38 Ortho Clinical Diagnostics (OCD) has received several complaints regarding quality control

fluid results that are below the measuring (reportable or dynamic) range for generation

(GEN) 72 of Vitros chemistry products NBIL DT slides when calibrated with Vitros chemistry

products DT Calibrator Kit Lots 37 and 38.

A) Steris 5085 Surgical Table

B) Steris 5085SRT Surgical Table

Steris Corporation 2011-11-28 2011-10-17 68312 Type III A) ST014101

B) ST014101

A) N/A

B) N/A

Steris Corporation has learned that a limited quantity of hydraulic column cylinders installed

into certain 5085 and 5085SRT Surgical Tables were assembled by the supplier with

incorrect snap rings and an anomaly in the tilt cylinder. These conditions may affect the flow

of hydraulic oil through the tilt cylinder and have the potential to affect the user's ability to

move the table top out of the full right tilt position.

A) Intralase FS Laser

B) IFS Advanced Femtosecond Laser

AMO Manufacturing USA, LLC. 2011-11-28 2011-10-27 68461 Type II A) FS, Model 2

B) Model IFS

A) > 10 Numbers, Contact Manufacturer

B) > 10 Numbers, Contact Manufacturer

Abbott Medical Optics Inc. initiated this event after becoming aware of a discrepancy in cut

depth that may affect deep corneal incisions (e.g. 300 micrometres or deeper) created using

the femtosecond laser system. This discrepancy between the user-set depth of corneal

tissue incision and the actual depth of those incisions was discovered during an engineering

investigation conducted prior to the launch outside the united states of a new indication for

arcuate incision procedures. The engineering investigation was not initiated due to the

receipt of a complaint.

VITROS Chemistry Products Calibrator Kit 24 Ortho-Clinical Diagnostics Inc. 2011-11-28 2011-10-28 68645 Type III 6801708 All Ortho Clinical Diagnostics (OCD) has received complaints of lower than expected results for

control fluids and patient samples upon initial calibration or following recalibration using

Vitros Chemistry Products Calibrator Kit 24 and Vitros Chemistry Products Malb Reagent.

All current lots of Vitros Calibrator Kit 24 may experience a change in performance over

time, which will yield lower than expected results when they are used to calibrate all current

Gens of Vitros Malb Reagent.

Lupine BR Anchor with Orthocord Depuy Mitek 2011-11-28 2011-11-01 68691 Type II 210711 3549273 Depuy Mitek is initiating a recall of a specific lot of Lupine Loop Anchor because of a

manufacturing assembly issue. The lot was assembled with an incorrect suture

configuration. If the incorrect suture configuration goes undetected it could result in a loose

repair.

Curix Opthos H 35x43cm, NIF Agfa Corporation 2011-11-28 2011-10-07 67769 Type III 35HJQ 79890049 When used in a clinical environment, the Curix Opthos H Film described above, "flipped" or

"reversed" , loaded in a Curix Opthos H Asymmetric screens and cassette and exposed as

normal, may be viewed to have slightly different image quality than the expected normal

Curix Opthos H image quality.

Colgate Motion Electric Toothbrush Colgate - Palmolive Canada Inc. 2011-11-28 2011-11-03 68604 Type III Colgate Motion, Colgate Motion Whitening > 10 Numbers, Contact Manufacturer Colgate-Palmolive Canada Inc. is initiating a recall of Colgate Motion and Colgate Motion

Whitening battery toothbrushes due to a small number of reports received involving rapid

gas venting of the battery which may cause the battery cap to suddenly burst from the unit

resulting in a loud noise. There have been no serious injuries resulting from the reported

events.

Brainscan Platform Software BrainLab AG 2011-11-28 2011-11-07 68664 Type II 20140A, 20140B, 20140C, 70140, 70151C N/A The Brainscan Pencil Beam dose algorithm may overestimate the dose delivered to the

targeted region if certain conditions are met. As a consequence, doses lower than planned

might be delivered to the patient, potentially resulting in ineffective treatment.

Bard Encor Biopsy Probes Senorx Inc. 2011-11-28 2011-11-09 68766 Type II ECP01-10G, ECP01-10GV, ECP01-12G, ECP01-12GV, ECP01-7G, ECP01-7GV,

ECPMR01-10G

> 10 Numbers, Contact Manufacturer The manufacturer has confirmed that a limited number of units from specific product code /

Lot number combinations of the Encor Biopsy Probes may have packaging damage

resulting from transportation. The packaging damage ranges from broken trays to visual

cosmetic defects of the trays.

3160 MRI Patient Monitoring System (Precess Unit) Invivo Corporation 2011-11-28 2011-09-23 68277 Type II 3160DCU (865112), 3160WPU (865113) 00475 (3160DCU), 0000A30765 (3160DCU),

0000A30766 (3160DCU), 0000A30771

(3160DCU), 0000A30765 (3160WPU),

0000A30766 (3160WPU)

Loss of communication between the wireless processing unit and the display controller unit

may cause unprompted changes to alarm high and low limit values and to the units of

measure for some parameters.

Endolite 30mm Pyramid Clamp Adaptors Blatchford Products Ltd. 2011-11-28 2011-08-08 68508 Type III 409028, 409054 P265 to P365,

Q001 to Q365,

R001 to R365,

S001 to S365,

T001 to T048

A small number of failures (0.85%) have been reported where components have cracked

unexpectedly, both at the fitting stage and after a period of use. Similar failures could result

in the limb wearer falling and injuring themselves.

A) Broselow/Hinkle Pediatric Emergency System Kit

B) Broselow/Hinkle Pediatric Emergency System Flying Carpet

C) Broselow/Hinkle Pediatric Emergency System IV Module

D) Broselow/Hinkle Pediatric Emergency System Intubation

Module

E) Broselow/Hinkle Pediatric Emergency System Intraosseous

Module

F) Broselow/Hinkle Pediatric Emergency System Oxygen

Delivery Module

G) Broselow/Hinkle Pediatric Emergency System Pouch, Bag

and Tag Pack

Vital Signs Inc. 2011-11-28 2011-09-27 67377 Type II A) 7730AL, 7730BLU5, 7730GRN5, 7730IALS, 7730MOD, 7730ORG5,

7730PUR5, 7730RED5, 7730WHI5, 7730YEL5

B) 7730FLY

C) 7700BIV2, 7700GIV2, 7700OIV2, 7700PIV2, 7700RIV2, 7700WIV2, 7700YIV2

D) 7700RIN2

E) 7700RIO2

F) 7700RAW2

G) 7730POCH

A) > 10 Numbers, Contact Manufacturer

B) > 10 Numbers, Contact Manufacturer

C) > 10 Numbers, Contact Manufacturer

D) > 10 Numbers, Contact Manufacturer

E) > 10 Numbers, Contact Manufacturer

F) > 10 Numbers, Contact Manufacturer

G) > 10 Numbers, Contact Manufacturer

Vital Signs Devices, a GE Healthcare company has become aware of a safety issue

associated with Povidone Iodine Pad included in the Vital Signs Broselow Pediatric

Emergency System Kit. The manufacturer of the Povidone Iodine Pad, H&P Industries, is

conducting a field corrective action to address a potential contamination of these products

with an objectionable organism, Elizabeth Kinga MeningoSeptica.

Enflow IV Fluid Warmer Enginivity LLC 2011-11-28 2011-11-09 68642 Type II 980100, 980105VS > 10 Numbers, Contact Manufacturer,


GE Healthcare has become aware, through customer complaints, of a safety issue

associated with Enflow IV fluid warmer. There is an issue that can result in an excessive

external surface temperature on the underside of the enflow warmer which can result in

potential burns to patients or clinicians who touch the device.

Vancomycin Calibrators Seradyn Inc. 2011-11-28 2011-11-01 68675 Type III 196076 Unknown Microgenics / ThermoFisher has confirmed an average shift in results of approximately

+22.6% when using the Vancomycin Calibrator Lot #59391741 (expiry date December 31,

2011). Microgenics / ThermoFisher investigation is underway to determine root cause and

determine correction for future Lots.

Premier EHEC Meridien BioScience Inc. 2011-11-28 2011-10-12 67996 Type III 608096 608096B149, 608096B151 Internal testing has shown that the indicated kits produce false negative results when tested

with some direct stool specimens. These false negative reactions are not observed for all

devices tested, however, the rate of occurence will likely impact clinical sensitivity as

defined by product registration and associated instructions for use.

APB Monitor Spacelabs Healthcare Ltd. 2011-11-28 2011-11-01 68677 Type III 90217A 217A-000780, 217A-000872, 217A-000018,

217A-000026, 217A-000133, 217A-000134,

217A-000181, 217A-000195, 217A-000204

Reports of abp recorders showing an EC75 error code and ceasing to function. When this

happens the power must be cycled off and on to restore functionality. No one has been

injured as a result of this issue.

Ligasure Dolphin Tip Sealer/Divider Covidien LLC 2011-11-28 2011-11-10 68841 Type I LS1500, LS1520 Model# LS1500: Lots S1CB001 through

S1JB048X,

Model# LS1520: Lots S1CB010X through

S1HB013P

The recall is being conducted due to the potential for the handle pins to disengage which

could compromise handle unlatching. This may complicate removal of the device jaws from

targeted tissue. In an open procedure, there is a risk that the disengaged handle pin may fall

into the patient cavity and go unnoticed.

Softbank II V.23.2/25.0/25.1 SCC Soft Computer 2011-12-12 2011-09-16 68455 Type II V.23.2, V.25.0, V.25.1 All Lots When printing an ISBT label for blood product with an expiration time of midnight (00:00),

the generated label prints 23:59 instead as the expiration time in the barcode. The unit can

be mislabeled with a falsely extended expiration time.

Delta Q Sterilizer Pelton and Crane 2011-12-12 2011-10-31 68810 Type III 054200, AF S/N 20182 The front panel had missing segments on the display panel because not all display

segments were illuminating properly.

D-Spect Cardiac Scanner System Spectrum Dynamics (Israel) Ltd. 2011-12-12 2011-07-18 68848 Type III N/A N/A During routine operations, the detectors housing is manipulated for best positioning. If the

detector head is pulled or pushed aggressively and repeatedly, this type of handling might

result in extreme cases, the detector head to slide out from the gantry. In this case possible

damage to the system or contacting with patient's legs might occur.

Vitros Chemistry Calibration Kit 16 Ortho-Clinical Diagnostics Inc. 2011-12-12 2011-11-11 68859 Type III 6801700 1630 Ortho Clinical Diagnostics (OCD) was notified by its supplier that lot 1630 of Calibration Kit

16 would not meet its specified 12-month stability. OCD testing indicates that patient results

generated using Vitros Chemistry Products RF reagent calibrated with Vitros Calibrator Kit

16, Lot 1630 may demonstrate a positive bias across the measuring range of 8.6-120 iu/ml

if a new calibration is performed. The positive bias is readily identifiable by routine post-

calibration quality control testing with control fluids. To date, OCD has not received any

complaints related to this issue.

Aquilion 64 System Toshiba Medical Systems Corporation 2011-12-12 2011-10-27 68829 Type III TSX-101A/H, TSX-101A/HX S/N: HCB0993654, HCB1023752, HCB10X3839 In some Aquilion 64 Systems, the Dose Length Product (DLP) Value is displayed incorrectly

when the optional Variable Helical Pitch (VHP) is used.

A) Hitachi and Modular P Theophylline

B) Cobas Integra Theophylline for Cobas C Systems


B) 04491025190

A) 65122701

B) 65123301

Possible elevated recovery in patient samples observed with the Cobas Integra

Theophylline for the Hitachi/Modular P Theophylline of Lot No. 65122701

A) Encore 100 Sphere

B) MediFlex Aquafinity 125

C) 2 Clear Comfort

Coopervison Inc. 2011-12-12 2011-11-17 68974 Type I A) Encore100 Sphere

B) MediFlex Aquafinity 125

C) 2 Clear Comfort



C) Contact Manufacturer

Certain lots of the affected lenses did not meet the new manufacturing acceptance limit for

the presence of residue (Silicone oil) which may cause hazy vision or discomfort, severe

eye pain or eye injuries requiring medical treatment.

Truebeam (Radiotherapy Configuration) Varian Medical Systems, Inc. 2011-12-12 2011-05-13 69035 Type II N/A H191038 It has been determined that some drive stand bolts may fail to meet mechanical

specifications. These load - bearing stand bolts are used to secure the drive stand

assembly to the base frame. Failure of some of the gantry stand rear bolts may lead to a

shift of the linear accelerator isocenter. The affected bolts were isolated to a single lot of

bolts supplied to Varian.

A) Safesheath CSG Hemostatic Introducer

B) Safesheath Lateral Vein Introducer

Thomas Medical Products, a GE Healthcare Company 2011-12-12 2011-10-07 68375 Type I A) CSG/WORLEY/BCOR-1-09, CSG/WORLEY/BCOR-2-09,

CSG/WORLEY/L/BCOR-1-09

B) LVI/75-5-62-07-HS, LVI/75-5-62-07-MP, LVI/75-5-62-07-RE, LVI/TELE/B-60-07-

HO, LVI/TELE/B-60-07-MP, LVI/TELE/B-60-07-RE



The radiopaque segment may detach during in vivo use resulting in device fragments that

will remain in the patient's vasculature.

Digital Diagnost Philips Medical Systems DMC GMBH 2011-12-12 2011-11-04 68644 Type II 9890-010-83903 N/A Potential for a small metal protective cover on the bottom side of the control handle for the

ceiling suspension is missing. This exposes electrically live parts on the printed circuit board

of the control handle to the potential for direct contact. The live voltage is small (25 volts)

but is a deviation from the IEC Standard 60601-1.

Expression MRI Patient Monitoring System-Main Unit Invivo Corporation 2011-12-12 2011-11-02 68680 Type II 865214 N/A Over time, it may be possible for all six nuts securing the dcu to the cart may become

disengaged from the DCU docking plate. As a result, a docked dci may become unbalanced

and fall off the cart during transport or during tilting of the docked DCU.

Outlook 621-ES100 B. Braun Medical Inc. 2011-12-12 2011-08-26 68771 Type II 621-100ES, 621-200ES, 621-300ES, 621-400ES >10 Numbers, Contact Manufacturer The Outlook ES Dose Guard Care Area can inadvertently be exited when the pump enters

the KVO (Keep Vein Open) state when a sequence of hold-hold key strokes are performed

on the pump key panel.

A) Custom Sterile Cataract Pack

B) Sterile Eye Custom Pack

C) Custom Eye Preparation Pack

D) Eye Pack

E) Day Surgery Pack

F) Cartoid Pack

G) Custom Sterile Plastics Pack

Cardinal Health 2011-12-12 2011-11-07 68861 Type II A) N/A

B) N/A

C) N/A

D) N/A

E) N/A

F) N/A

G) N/A

A) 027037, 031646, 046301, 027665, 042484,

046654

B) 034330, 041614

C) 030707, 040090

D) 030220, 032852, 045786, 026659, 043922

E) 033349

F) 030076

G) 025031, 0253031

The recall was initiated due to the possibility that a small percentage (approx 1.5%) of the

BD 30g needles (catalog 300745, lot 1116090) contained in Cardinal Health Custom Sterile

Packs may be clogged.

Alaris PC Model 8015 CareFusion 303 Inc. 2011-12-12 2011-11-02 69106 Type II TC10005122 N/A A problem with the power supply board used with the Alaris PC Unit Model 8015 only. A

component on this power supply board is drawing extra charge and depleting the battery

sooner than expected. The initial low battery message/ alarm will indicate that the battery

has less than 30 minutes before depletion. However the battery power may not be available

for the time indicated. If an affected power supply board is used in a PC Unit the battery

may not last as indicated by the low battery message/alarm. If the PC Unit is not plugged

into an A/C outlet as soon as the low battery message appears, this could stop infusion or

delay therapy which may result in serious injury and/or death.

Osteonics Restoration Hip System - Reduced Neck Hip Stem -

Straight

HowMedica Osteonics Corporation 2011-12-12 2011-10-31 68646 Type II S-2653-0812L/R N/A Stryker orthopedics has identified an issue whereby an incorrect laser mark was noted on

specific lots of the product. The stems read "t#9stm-30nk" but should read "t8stm-30nk".

This error incorrectly implies the stem is a size #9, when the stem is actually size #8.

A) Evo 4 Electrode Hookup Kit

B) Aria Hookup Kit

C) Lifecard Holter Hookup Kit

SapceLabs Healthcare Ltd. 2011-12-12 2011-10-21 68681 Type II A) 50-0048, 50-0049

B) 23189-106

C) 23189-116

A) B33973

B) B33901, B33905

C) B33901, B33905

Potential hazard associated with the use of pdi alcohol prep pads. These non-sterile alcohol

prep pads are included in Spacelabs Healthcare Hook-up kits and may have the presence of

a bacterium, bacillus cereus, which could lead to life-threatening infections.

Sequencer Elekta Business Area Software Systems Impac Medical

Systems, Inc.

2011-12-12 2011-11-02 68776 Type II N/A N/A Issue with Mosaiq that could affect any treatment field defined with MLC leaves at the time

of RTP import of treatment plans. A product defect truncates the MLC leaf values upon the

import of a treatment plan after the 3D image viewer has been opened, if the workstation on

which the import was executed is configured to use a comma(,) as the decimal separator.

This involves sequencer for Mosaiq 2.20.08 (first build released May 2011) including all

released builds and service packs of version and version 2.00x3sp6 (first build released

Sept 2011).

A) Accu-Check Inform II Meter

B) Accu-Check Inform II + RF Meter


B) 05060303001

A) Software Versions 03.03.01 AND 03.03.00

B) Software Versions 03.03.01 AND 03.03.00

A possible software bug of the Accu-Check Inform II Meters with Software Versions

03.02.01 or 03.03.00 when configured to allow the operators to add new patient IDs.

Osseotite Certain Implant Biomet 3I (also Trading as Implant Innovations, Inc.) 2011-12-12 2011-10-11 68806 Type III IOSM313 2010111529 A small percentage of the implants may not have the internal thread which is necessary to

assemble mating components.

Infinity Acute Care System (IACS) Monitoring Solution Draeger Medical GMBH 2011-12-12 2011-10-11 68064 Type I MS25520 5610224874 The weight-based drug dosage calculation may deliver incorrect recommendation values if

the patient's body weight is not entered via the Admin-/Demographics screen, but entered

via the Drug Dosage application screen. One hospital in Germany also reported a

misalignment of ECG and Art Waveforms delivered from this product.

Nucleus-X Catheters Numed Canada Inc. 2011-12-12 2011-10-20 68643 Type III PVN409 YX-0053, YX-0054 Numed canada inc. incorrectly labeled 9 catheters. 3 units are still in inventory at numed

canada and 6 units were shipped with the wrong lot number prefix on the box label.

A) DuraHook Scalp Retractor

B) DermaHook Skin Retractor

Teleflex Canada 2011-12-12 2011-11-21 69006 Type II A) 382800

B) 382805


B) 01E1000026, 01A1100370, 01G1000251,

01H1000296, 01J1000298, 01K1000051,

01L1000282, 01M1000199, 01M1000200

The elastic bands on the Neuro Elastic Retractors are breaking within the sealed packaging

or during use prior to their expiration date.

Synergy XVI Elekta Limited 2011-12-12 2011-10-14 68287 Type II MRT14921 All Affected XVI 4.5 If you make a correction where you move the Clip/Mask slider in the Clipbox, it can move

the critical structures in an incorrect direction. This only occurs if there is a large rotation in

the Clipbox registration. Elekta recommends to do an image review to make sure that the

end result is correct. If error not seen and treatment table correction has been applied, it can

cause clinical mistreatment.

Dimension Vista System- V-Lyte Integrated Multisensor Na K

Cl

Siemens Healthcare Diagnostics Inc. 2011-12-12 2011-11-02 68678 Type III K820, K825, K835 KA1G01, KA1H01, KA1J01, KB1G02, KB1J01,

KB1K01, KE1H01, KE1J01, KE1K01

May cause reduced V-Lyte integrated multisensor on-board use life as demonstrated by

increases in urine QC sodium results within 48 hours after installation of a new IMT sensor.

The QC results can be elevated approximately 10-20% which results in urine QC results

rising out of acceptable QC ranges.

Solis Trial Cage Stryker Spine SAS 2011-12-12 2011-11-07 68821 Type III 8741206, 8741207, 8741209, 8741404, 8741406 91854, 10G655, 10G757, 10F956, 08C688 It was detected in QC control that the hole used to thread the Solis Trial onto the implant

holder was manufactured on the left side of the instrument instead of the right as indicated

on the engineering print. This leads to the trial being placed upside down on the handle. The

implant handle has markings indicating the cranial and caudal sides on the top and bottom

respectively. The nonconforming trials result in the cranial side of the trial being inserted

facing caudal.

Dyonics Electroblade Resector - Full Radius Smith & Nephew, Inc., Endoscopy Division 2011-12-12 2011-11-07 68862 Type I 7205962 897191, 868519, 868509, 863004, 830569,

830568

A manufacturing issue has been identified that may result in the distal tip of the outer sheath

(return electrode) detaching and becoming loose in the joint during use.

Drill Bit Synthes (Canada) Ltd. 2011-12-12 2011-11-14 69107 Type II 03.010.228 All Lots / Tous les Lots Synthes (Canada), Ltd. Is initiating a medical device recall for the drill bit due to the

potential for the drill stop to slip on the reamer. If the drill stop slips on the reamer, it may

cause deeper reaming than intended, and in rare cases, penetration of the joint space

causing pain and/or joint irritation.

SPOT-Light HER2 CISH Kit Life Technologies Corporation 2011-12-12 2011-10-19 69187 Type II 84-0150 Lot 1029335 It was determined that lot number 1029335 of SPOT-Light Her2 CISH Kit includes Reagent

H that may be contaminated with lecanicillium fungicola, a fungal contaminate.

3.5mm Super 90-S Serfas Energy Probe Stryker Endoscopy 2011-12-12 2011-10-31 68647 Type II 0279-351-300 11161AE2 to 11241AE2 Stryker was aware of a higher risk of tip breaks for the Serfas Energy Probe.

AW Server GE Emdical Systems, LLC 2011-12-12 2011-11-25 68684 Type II 5317169-X >10 Numbers, Contact Manufacturer Issue #1 (Volume Viewer): on monitors with 2 megapixel (2MP) resolution and higher (i.e.

higher than 1600x1200 resolution), for a certain sequence of user commands, switching

between two Volume Viewer tabs with different patients, the topmost strip of the Volume

Viewer display fails to update between patients. This causes the incorrect (i.e., first) patient

name to display in the topmost viewports when the second patient's image data is displayed.

The lower viewports display the correct patient name, as does the patient name tab. Issue

#2 (Results Viewer): on AW Server, the results viewer application may take 5-8 seconds to

initialize and display a selected patient exam when first started. If a second patient exam is

selected before this initialization has completed, the second patient's data will be displayed

in the viewports with the corresponding patient name on the viewports. However, the first

patient's name will be displayed on the applications tab.

BIS Bilateral Sensor Covidien LLC 2011-12-12 2011-11-09 69209 Type I 186-0212 0607111A A recent modification of the BIS Bilateral Sensor reversed the reference electrode and the

left eye electrode. This change will result in the inaccurate calculation and presentation of

processed Electroencefalography(EEG) information for Bispectral Index (BIS), Density

Spectral Array(DSA) and Asymmetry (ASYM) values.

Super Torque MB Angiographic Catheter Cordis Corporation 2011-12-12 2011-11-25 69239 Type II 532-598A, 532-598B, 532-598C, 532-598D 15435050, 15402631, 15257142, 15247189,

15206620, 13431281, 15277504, 13460575,

13467459

Cordis has issued a Field Safety Notice to provide important information concerning a

potential for marker band dislodgement in the Super Torque MB Angiographic Catheter

during endovascular procedures when the catheter is stretched or elongated, and important

recommendations for clinical use.

A) Gamma XXL

B) Delta Monitor

C) Delta XL Monitor

Draeger Medical Systems, Inc. 2011-12-28 2011-10-25 68425 Type II A) MS18852

B) MS18597

C) MS18596

A) 5398255564, 5398293656, 5398294156,

5398294254, 5398294949, 5398754355



Ventricular fibrillation (VFIB) arrhythmias may not be recognized by the monitor and may

not alarm when the Masimo Set Pod is used for SPO measurements.

Infant Radiant Warmers Fisher and Paykel Healthcare Ltd. 2011-12-28 2011-11-11 68668 Type II IW910, IW920, IW930, IW931, IW932, IW933, IW934, IW950, IW951, IW952,

IW953, IW954, IW960, IW970, IW980, IW990

9891JEU00024 - 2001-98JEU00195, 010824 -

100930

The movement of the warmer head can put stress on the head harness connector.

Prolonged exposure to this stress can lead to electrical arcing at the connector which may

lead to discolouration, occasionally charring of the electrical connector or it can lead to a

loss of electrical power to the heating element.

A) Bivona Tracheostomy Tubes TTS - Pediatric/Neonatal

B) Bivona Tracheostomy Tubes Flex-Tend - Pediatric

C) Bivona Tracheostomy Tubes Aire-Cuf - Pediatric/Neonatal

Smiths Mdical ASD Inc. 2011-12-28 2011-11-29 69167 Type II A) 67N025, 67N030, 67N035, 67N040, 67P030, 67P035, 67P040, 67P045,

67P050, 67P055

B) 60PFP40, 60PFP45, 60PFS30, 60PFS40, 60PFS50, 60PFSS45

C) 60N025, 60N035, 60N040, 60NFP25, 60NFP30, 60NFP35, 60NFP40, 65P025,

60P030, 60P035, 60P040, 60P045, 60P050, 60P055, 65P025, 65P030, 65P035,

65P040, 65P045, 65P050, 65P055

A) 1631477 - 1923406

B) 1631477 - 1923406

C) 1631477 - 1923406

Smiths Medical has become aware of a small number of complaints of customers

experiencing difficulty disconnecting accessories from the connectors of the affected tubes.

In some cases, the customer was unable to disconnect the accessory or excessive force

lead to decannulation of the tube, and an emergency tracheostomy tube change was

required. If the accessory is correctly connected to the affected tubes, then there will be no

issue with disconnection.

XVI R4.5 (X-Ray Volume Imaging System) Elekta Limited 2011-12-28 2011-10-20 69207 Type II MRT14921 G28421 - G35174 A small number of sites have experienced situations with KV Generator Transformers

overheating due to a diode failure on the interface board. If it occurs, it can cause non-toxic

smoke and small fires in the KV Generator. As this fault occurs inside the generator, in the

equipment room, the risk of injury to patients or hospital personnel is very small.

Tomotherapy Shareplan 1.1 Raysearch Laboratories 2011-12-28 2011-10-10 68876 Type III 1.3.1.10 S/N 1.3.1.10 Behaviour of the Shareplan may be unexpected and not cleary described in the user manual.

Acrobat V Vacuum Stabilizer System Maquet Cardiovascular LLC 2011-12-28 2011-11-24 69278 Type II OM-9100S 25040646 As a result of product quality monitoring, it was brought to our attention that there might be a

small perforation in the sterile pouch of these products. An investigation revealed this small

perforation potentially occurring due to manufacturing related causes. As a result, there is a

potential for the pouch integrity to be compromised, which may result in compromised

sterility of the product. The patient risk is that if the compromised product is used in surgery

it may result in an increased chance of infection for the patient.

VenaCure EVLT NeverTouch Procedure Kits Angiodynamics Inc. 2011-12-28 2011-11-11 69279 Type I 11403001, 11403003 549607, 549609, 552940 The hemostasis sidearm assemblies have the potential for flash to exist on the housing at

the base of the threads. This flash has the potential to break off and relocate within the fluid

path. If the flash found at the base of the housing of the hemostasis valve were to break off

and enter the fluid path of the product, it could potentially be flushed into the patient's

venous system. This condition would not be obvious to the end user.

Cryocheck Abnormal 2 Reference Control Precision Biologic Inc. 2011-12-28 2011-11-29 69302 Type III ARP2-10 9054 The product code etched onto the outer box of the above named product contains a

typographical error. The code reads "APR2-10" instead of "ARP2-10". The product code on

the immediate product container (Vial) is accurate, as is all other labelling accompanying

the product.

Coulter Cyto-Trol Control Cells Kit Beckman Coulter, Inc. 2011-12-28 2011-10-17 68310 Type II 6604248 7319028K, 7319029K, 7319030K, 7319031K The CD2 Assay value assigned for the affected kits is incorrect, and may cause a delay in

the ability to report CD2 values if the control values are out of the assigned range.

Visum LED Surgical Light Stryker Communications 2011-12-28 2011-11-09 68822 Type II 0682-001-252, 0682-001-253, 0682-400-137, 0682-400-138 0682-001-252, 0682-001-253, 0682-400-137,

0682-400-138

The Visum LED Surgical Lights are intended to illuminate operative sites during surgical

procedures with high intensity light. Stryker's analysis has revealed that it is possible for the

Visum LED Surgical Light to separate from the arm.

Pinnacle 3 Radiation Therapy Planning System-SmartArc

Module

Philips Medical Systems (Cleveland), Inc. 2011-12-28 2011-11-17 69142 Type II 4535 604 46041 N/A Philips has become aware that when the user changes the machine for step and shoot

beams from a fixed jaw to a variable jaw machine, the jaws may change from symmetry to

asymmetry to duplicate the original beam, but the jaw symmetry yes/no option remains set

to yes. When exported via Dicom RT, the Multileaf Collimeter (MLC) and jaw positions

agree with the Pinnacle Plan. However, because the Jaw Symmetry Flag is set to yes, the

Record and Verify (R&V) system may force the jaws to be symmetric, thereby re-positioning

the beam. The resulting beam on the R&V side does not match the beam in Pinnacle.

A) Axis Variable-Angle Dual-Detector Gamma Camera

B) Irix Variable Angle Nuclear Imaging System

C) Axis Gantrys

D) Irix Gantry

E) Irix Triple Detector Camera

Philips Medical Systems (Cleveland), Inc. 2011-12-28 2011-11-17 69143 Type II A) N210623, N211037, N211039

B) N210856, N210879, N211038

C) N211280

D) N211281

E) N211040

A) N/A

B) N/A

C) N/A

D) N/A

E) N/A

Issue relating to Detector Buckets that may experience weakness over time. This could

cause the Detector Bucket to separate from the mounting plate of the Gantry and could

eventually result in the Detector falling.

150ml Burette Set Hospira Inc. 2011-12-28 2011-11-14 68808 Type II 19208 831075H The potential for the Float Valve (Automatic Shut-off Valve) to stick to the Burette and

therefore not open properly. If the Float Valve sticks,the Burette port will remain open after

administration of fluids.

A) Access Ostase Assay Reagents

B) Access Ostase Calibrators

C) Access Ostase QC


B) 37305

C) 37309

A) 011167, 014486, 017561



Affected Access Ostase Calibrator and QC Lots do not meet expiration date claims. As a

result, Quality Control and Patient Sample results may be falsely elevated by up to 14%.

A) AMH Gen II ELISA

B) AMH Gen II Calibrators and Controls

Beckman Coulter, Inc. 2011-12-28 2011-11-07 68858 Type III A) A79765

B) A79766

A) All

B) All

The Linear Curve Fit option is not an appropriate statistical model for the AMH Gen II ELISA

Assay. The calibrators may show a non-linear response.

Vitrea 2 Vital Images, Inc. 2011-12-28 2011-11-11 69160 Type II VPMC-11906, VPMC-11907, VPMC-11908, VPMC-11909, VPMC-11910, VPMC-

11911, VPMC-12018, VPMC-12020, VPMC-12021, VPMC-12022, VPMC-12023

Vitrea Enterprise Suites 6.0, Vitrea Enterprise

Suites 6.1

Two issues have been identified that may display incorrect Standard Update Values (SUV)

when viewing certain PET/CT images.

Medtronic SynchroMed II Implantable Programmable Drug

Pump

Medtronic Inc. 2011-12-28 2011-11-23 69281 Type II 8367-20, 8367-40 Contact Manufacturer,

Contactez Fabriquant

This field action is a follow-up to Medtronic customer notification regarding Synchromed II

Model 8637. Medtronic is now exchanging non-implanted Synchromed II Pumps containing

the original design batteries with pumps containing the new batteries.

Level 1 Normothermic IV Fluid Administration Sets Smiths Medical ASD Inc. 2011-12-28 2011-11-28 69398 Type II D-60HL, DI-60HL >10 Numbers, Contact Manufacturer Smiths Medical has become aware of an increased trend in reports of disconnections of the

Luer lock connector at the patient end of the tubing on certain sets. If the Luer lock

connector disconnects during use, this could result in fluid/ blood loss and/ or a delay in

therapy, which could result in patient injury or, while highly unlikely, death.

HOTLINE Blood and IV Fluid Warming Sets Smiths Medical ASD Inc. 2011-12-28 2011-11-28 69399 Type II L-70, L-70NI, L-80 >10 Numbers, Contact Manufacturer Smiths Medical has become aware of an increased trend in reports of disconnections of the

Luer lock connector at the patient end of the tubing on certain sets. If the Luer lock

connector disconnects during use, this could result in fluid/ blood loss and/ or a delay in

therapy, which could result in patient injury or, while highly unlikely, death.

Venous Arterial Blood Management System (VAMP) Edwards LifeSciences LLC 2011-12-28 2011-01-28 66473 Type II 48VMP120, PXVMP120, PXVMP160, PXVMP172, PXVMP260, PXVMP272,

PXVMP3X32, PXVP0568, PXVP2260, PXVP2284, PXVP23X3, VMP106

>10 Numbers, Contact Manufacturer A small percentage of units shipped from August 2010 - November 2010 could have a crack

on the bottom of the sample site, which could result in a small amount of leakage of

intravenous fluids or blood.

A) 1235 Autodelfia System - PAPP-A

B) Delfia Xpress 6000 Immunoanalyzer System - PAPP-A

Assay

Wallac OY 2011-12-28 2011-11-08 68863 Type II A) B098-201

B) 6003-0020

A) 610717, 610931, 612004, 612648

B) 609917, 610229, 610752, 610915, 611438,

611611, 612155, 612439

Change in reconstituted stability of papp-a standards/calibrators.

System Fujifilm FDR Acselerate Fujifilm Corporation 2011-12-28 2011-10-11 69104 Type II DR-XD-200G 5051 When switching exposure menus too quickly in the Dr Operator's console, the X-ray console

may only display the settings of a previous exposure menu, thus introducing the possibility

of delivering an incorrect exposure to a patient, or it may freeze.

Dimension Vista Cardiac Troponin I Calibrator Siemens Healthcare Diagnostics Inc. 2011-12-28 2011-11-17 69169 Type III KC678 1DD085 Siemens Healthcare Diagnostics have received customer inquiries for QC and patient shifts

following calibration with lot 1DD085. Internal testing has confirmed shifts with some

calibrator sets from this lot. Operations has tested one set of 1DD085 from six shipments

from the American Distribution Centre (ADC) in Indianapolis, Indiana to Glasgow, Delaware

and found two sets to recover within 3% of nominal, two sets to recover 3-5% below

nominal, and two sets to recover 5-7% below nominal. Calibrator sets recovering below

nominal will cause qc and patients to shift high. A patient shift of up to 26% may occur at

0.04 ng/ml which could change a sample to 0.05 ng/ml which is above the 99th percentile

upper reference interval (0.045 ng/ml).

Hospital Bed Revolution Sante (FASRS) 9191-6445 Québec Inc. 2011-12-28 2011-04-11 69293 Type III RS508 N/A The half bed rail jammed with the spring when lowered, which prevented it from being

lowered smoothly and quietly.

Electrosurgical Unit Celon AG Medical Instruments 2011-12-28 2011-11-30 69527 Type II ESG-100 25456W23-101, 25456W23-103, 25456W23-

104, 25456W23-105, 25456W23-109,

25456W23-110, 26879W23-101, 26917W23-

104, 25456W23-106

Olympus Canada Inc. (OCI) has initiated this recall following complaints received outside of

Canada associated with inconsistent or failed electrical output from the ESG-100.

Investigation of the customer complaints has revealed two capacitors mounted on the main

board of certain ESG-100 may be counterfeit components. Performance testing on ESG-

100s with counterfeit capacitors satisfied the established release specifications for this

product, but the performance of the counterfeit capacitors can degrade over time.

A) Coulter LH 780 Analzyer

B) Coulter LH750 Analyzer

C) Coulter LH500 Analyzer


B) 6605632

C) 178832, 178833, 178834

A) All

B) All

C) All

The Auto Stop and Auto Transmit features for Quality Control become disabled after

scanning assay values from Coulter 5C and Retic-C Cell Controls Assay Sheets using the

2D Barcode scanner.

Compat Enteral Delivery Sets Nestle Healthcare Nutrition Inc. 2011-12-28 2011-11-30 68865 Type III N/A 9519810, 9519805, 9521433, 9521434,

9522610, 9521429, 9521430

Nestle Health Science determined that drip chamber material in select codes of Compat

Enteral Feeding Administration sets produced prior to August 2009 may have caused slip-

off occurrences.

A) AW Volumeshare 2 with Functool Application

B) AW Volumeshare 4 with Functool Application

GE Medical Systems SCS 2011-12-28 2011-12-08 69654 Type III A) 5183685-X

B) 5342425-X

A) N/A

B) N/A

GE Healthcare has become aware that the Functool Application version 9.4.04B has an

issue that prevents "Function Application" from loading more than two series. The affected

Functool Software version was included in the previous GE Recalls.

Elecsys Digoxin Roche Diagnostics GMBH 2011-12-28 2011-12-08 69662 Type III 11820796322 All The product will have its corresponding instruction for use document updated in section

"Limitation - interference". Among the list of pharmaceuticals causing falsely elevated

digoxin values at concentrations of the recommended daily dose, nabumetone and

pentoxifylline were re-added and triamterene was removed. Nabumetone and pentoxifylline

are not new limitations. They were accidentally removed since last edition in June 2010.

MEDICAL DEVICES RECALL LISTINGS: 2011docshare01.docshare.tips/files/8606/86062548.pdf · A) S/5 Aespire 7900 SmartVent Anesthesia System B) S/5 Aespire Anesthesia Machine C) GE Darex-Ohmeda

Documents