md recalls 2011-eng

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MEDICAL DEVICES RECALL LISTINGS: 2011

Trade Name ManufacturerRecall Posting

DateRecall Start Date Recall Number

Hazard

ClassificationModel or Catalog # Lot or Serial # Rea

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 i

or partially open position, resulting in flow

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 AnalyzerF) 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) 4768F) 476501

G) 476100

H) 4771

I) 4772

J) 4773

A) All lots

B) All lots

C) All lots

D) All lots

E) All lotsF) All lots

G) All lots

H) All lots

I) All lots

J) All lots

For user-defined chemistries (UDRS) in

the polychrome correction is not automa

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 affechoses, which become live when gradien

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

occur when using the Access Total BHCG

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 inco

shelf life and not fiv e years as indicated

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 T

housing is exposed to the operating volta

the persons performing repair or mainten

issue does not occur during normal clinic

components are enclosed behind the cov

A) Brilliance 64 Slice CT Sy stem - Extended Brilliance

Workspace (EBW)

B) Brilliance CT Big Bore System - Extended Brilliance

Workspace Portal

C) Brilliance ICT System - Extended Brilliance WorkspaceD) 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 applica

be labelled as being the percentage of in

diastolic and the end systolic states, but w

wall thickness from the end systolic to th

Kolibri Spectra Camera Kit Brainlab AG 2011-01-10 2010-11-30 59387 Type II 18117 5572110001 There exists a small probability that spec

resulting in navigation inaccuracies or in

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 optimiza

modulation at child head sequence whicVial-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-M

when used with I.V. bags that do not con

currently marketed in Canada are not inje

contain this minimum amount of air. The

the Vial-Mate device is used with the Via

A) Axiom Artis DTA

B) Axiom Artis FA AlphaC) 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, 200188C) 20069, 20070, 20151, 20163, 20215

D) 14041

A potential danger by the image intensifi

the image system can sporadically crash

apply contrast media and x-ray to the pa

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 operatingfibre at the connection to the laser conso

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 UnitG) 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 Sy stem - 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, M3335JGG) 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 NumbersG) 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 a

& not having another trained person on s

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

run (eg. A result of 1.025 would be trunc

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

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) manuf

result in the SCU losing communication,

intermittently cycle or stop working.


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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 inde

calculation from technical reference man

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

relabelled by a third party, and therefore

quality, and date of manufacture of the c

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 th

product pouch in the affected lots may no

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 nee

Catheter Kits may exceed USP requirem

A) ACL Elite

B) ACL Elite ProC) ACL 9000

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

B) 0001000311C) 0000990011

A) 05010100 to 10111176

B) 05010100 to 10111779C) 00040105 to 09031882

During testing of the ACL 8000/9000/100

APTT results were observed with availabrecombiplastin PT / synthasil APTT / rec

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

Legionella Growth Supplement Oxoid Limited 2011-01-10 2010-11-17 59075 Type II SR0110C 906009 Product may contain low level microbial

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 ele

high thyroglobulin (Tg) concentration (>2

S try ker N av ig at ion S ys te m - I nt el lec t C rani al S of twa re S tr yk er Lei bi nger G MB H & C o. K G 2 011 -0 1-1 0 20 10 -11 -3 0 594 27 T yp e I I 600 0-6 50 -00 0, 60 00- 65 0-1 00 , 6 000 -6 51- 00 0,

6000-651-200, 6000-652-000

3001, 3002, 3003, 3004, 3010, 3031 When the user imports two or more ima

image series, there is a potential that the

stored correctly by the system. This could

automatic correlation algorithm may not

image series may be shown with the wro

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 pro

test strips for specific l ots which can lead

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

Sealer/Divider. The recall is in response

device may energize when clamping with

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, wh

could be too long. 2) An inductor (lead) c

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

contained another part number 01-7112

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

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 proassociated with improper use and handli

serious injury. 2. Customers not aware o

regulators, ensuring their continued integ

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 pro

associated with improper use and handli

serious injury. 2. Customers not aware o

regulators, ensuring their continued integ

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 m

A) RELI SSO HLA-B Typing KitB) 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) 840.01B) 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 control release testing of the RELI SSO H

interpretation using the approved manua

may cause a mistyping or no typing resu

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

A) Contact Manufacturer

B) Contact Manufacturer

The manufacturer revised the endogeno

systems. The limitations-interference sec

been updated to indicate the impact of icof 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

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 M90234

that may yield falsely high I g-A results in

formulated with Ig-M monoclonal antibod

A) Stellaris Vision Enhancement W/AVSB) Stellaris Vision Enhancement W/AFS

C) Stellaris Vision Enhancement-Anterior Deluxe System

W/AVS & HSV

D) Stellaris Vision Enhancement W/AFS, HSVE) 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,

SYS01040C) SYS00397, SYS00656, SYS00806,

SYS00280, SYS00466, SYS00688, SYS00689,

SYS00661, SYS00509, SYS00169, & SYS00494D) SYS00446, SYS00139, SYS00514,

SYS00136, SYS00170, SYS00447, SYS00171,

SYS00564, SYS00570

E) Contact Manufacturer

Alert issued on reports of sparking, charAbbott Nutrition which are similar to the o


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A) Acuson Antares System-Main UnitB) 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, 10096B) 111994

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

113510, 116172, 116181, 116198, 116199,

113469, 115300, 114916, 116012, 116015,

115723

Advisory notice to notify af fected custom

through the following workflow steps 1) z

go to exam review or an offl ine workstat

results may be incorrect with no indicatio

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 tens

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 syr

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 poten

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 durin

damaged and locking mechanism is in athe unlocked status which could result in

Platelia Toxo IgG Bio-Rad 2011-01-24 2010-12-20 59953 Type II 72840 0D0017, 0D0117 Lower than expected R4A / R3 ratios tha

below 5.00.

O ly mpu s P edi at ri c R ese ct ion E le ct rod es Ol ym pus W int er & I BE GM BH 2 011 -0 1-2 4 20 10 -12 -1 6 599 88 T yp e I I A 370 08A , A 3700 9A , A 37 010 A, A 370 11A , A 3701 2A , A 37 013 A A ll L ot s, C ont ac t M anu fac tur er D ur in g p ac kagi ng v al id at ion t est in g, Ol ym

sterile package may fail after exposure to

shipping conditions.

R EN AS YS Po rt - Fo am D re ss in g K it P or t S mi th & Ne ph ew In c. W ou nd Ma na ge me nt

Division

2011-01-24 2010-12-21 59964 Type II 66800694 >10 Numbers, Contact Manufacturer Small holes in the primary pouch of som

package integrity which compromise the

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 histo

using SoftReports. If more than one qua

but all orders are listed under each patie

no way to distinguish what results belong

Expert DC Intraoral X-Ray System with Wall-

Mounting Plate

Imaging Sciences International, LLC DBA Gendex Dental

Systems

2 011 -0 1-2 4 20 10 -12 -2 0 599 76 T yp e I I 110 -02 07 G1 ( 120 V AC ), D 800 WP EX PE RT A ll L ot s T he w al l-m oun ti ng p la te i s d ef ec ti ve a nd

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 m easurement, t

then any results reported for the fraction

FMETHB and FHHB) will be values taken

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 cas

ventilated in high frequency oscillation (H

permanent patient injury occurred. Inves

mean airway pressure caused insufficien

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 Blan

may fail calibration after the reagent has

following reagents Digoxin, ACET, LIP, D

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 po

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"

Sheath with 5800 S series IAB products.

is unable to move the IAB catheter forwa

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 5m

potential defect in packaging. This packaof the device and/or may cause prematu

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 beca

Teledyne instruments. The defect may c

one of the INOmax drug-delivery system

observe erratic readings of nitric oxide (N

during use with patients. Because the o2

component, rather than the drug-delivery

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

could cause fragments to come into cont

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 T

which confirmed a labelling error with TA

within the kit. The TheraScreen: K-RAS M

an expiration date of 27 April 2011, howe

the kit is incorrectly labelled with an exp

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 cer

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

014769, was not met.

Access Immunoassay Systems Alpha-Fetoprotein (AFP) QCKit

Beckman Coulter, Inc. 2011-01-24 2010-12-13 59925 Type III 33219 012781 Access AFP QC Kit Beckman Coulter has confirmed that kitand QC3: 012780) of Access AFP QC m

included in the kit.

NanoCross .014" OTW PTA Dilation Catheter

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

EV3 Inc . 2 01 1- 01 -2 4 2 01 0- 11 -2 2 5 9 26 1 Type I AB14W020080150, AB14W020120150, AB14W025120150 8778807, 8784857, 8811586, 8815410,9248597, 9416365

Specific lots of t he catheter may crack o

or deflate the balloon and can result in m

A) PK7300 Automated Microplate System - Instrument Class 3B) PK7300 Automated Microplate System - Instrument

Beckman Coulter, Inc. 2011-01-24 2010-11-29 59926 Type II A) PK7300B) PK7300

A) All LotsB) All Lots

Beckman Coulter has confirmed that on reagent probes during testing on the PK7

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

10cc of powder rather than the 5cc label


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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-repeata

associated error message. These elevat

99th percentile of the reference populati

occurs, the CTNI result would be expecte

including the classic rise and fall in conce

M on ac o R TP Sy st em - V MA T O pt io n E le kt a B us in es s A re a S of tw ar e S ys te ms A TA

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) dos

Overestimation of dose in the treatment

A) Engstrom Carestation

B) Engstrom Carestation - Trolley Options


Datex-Ohmeda, Inc. DBA GE Healthcare 2011-01-24 2008-02-12 4 0775 Type II A) 1505-9000-000B) 1505-8538-000


B) CBCL0047 TO CBCL00453 & CBCL00458

Dual fault failure mode of Engstrom syste

pressures to exceed the user settable PM

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

values after specimen is prepared with im

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 testin

a result the units have the potential to fai

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

subsequently prevent those from overhe

adhesive labels) will be attached to the c

RTP Sof tware Monaco Elek ta Business Area Sof tware Systems ATA C omputeri zedMedical Systems Inc.

2011-01-24 2010-12-30 60327 Type II Monaco Release 2.03 & higher If the isocenter location is edited in the IMin the IMRT plan report. The problem oc

defined in the sim activity and then edite

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 Dec

recall. Codman has recently identified

disposable drills. Cracks have been id

these products are contained. The pro

and could result in an increased risk

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 sterilizatsimulate worst case use situations and m

steam sterilization duration has to be ext

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 s

a higher than expected variability in repo

periods of time in excess of 12 hours. Th

are stored refrigerated and warmed to ro

TomoTherapy Treatment System - Kit Power TomoTherapy Incorporated 2011-02-07 2010-12-28 60304 Type II 101264 10332, 10333 TomoTherapy has discovered an anoma

procedure, which consists of 2 to 12 bea

emergency stop during a short time perio

that the procedure will indicate a "perform

station. If this occurs the user will not be

TomoTherapy's investigation revealed th

stop occurs with 100 Numbers, Contact Manufacturer





F) >100 Numbers, Contact Manufacturer

There could be a sticky substance on the

manifest itself in approximately 6 t o 8 mo

Inotech Heparin Adsorbant Connectorate AG 2011-02-07 2011-01-21 60454 Type II HA-1-N N/A Inotech Heparin Adsorbant is being reca

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, 81631NZTB) 00391Z97, 009620AK, 021422A7,

82341PEQ, 90261S5R, 91411UKV, 92721X4R

The sterile barrier of the packaging may

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

Verification

Abbott Point of Care Inc. 2011-02-07 2010-12-29 6 0280 Type III 06F12-02, 06F13-02, 06F14-02, 06F15-02 M102081, M102082, M102083, M10208 It was found that there was a higher than

calibration verification level 1 that were o

Internal studies have determined that thethe cause of high results. Venting the ga

that may be present prior to the thawing

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

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 oc

within the EPGS of the System 1.


5/46

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 notificati

batteries should not be used with Infus O

incorporates a feature that may inhibit el

pump to power up.

COULTE R LYSE S I II di ff Ly ti c Reagent Beck man Coult er, Inc. 2011-02-07 2010-12-27 6 0297 Type I I 6605523, 6605526, 6605360, 723585, 6605632, 178833, 6605122, 6603208 Lyti c R eagent 101554F COULTER LYSE S I II dif f Lyt ic Reagent

customers prior to completion of QC test

(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 adde

manufacturer has received reports where

extracorporeal circuit resulted in air ente

Latitude Secure Server Cardiac Pacemakers Incorporated 2011-02-07 2011-01-10 60523 Type III 6441 N/A Data within printed reports obtained from

accurate. Specifically, when printing repo

recent presenting electrogram (MRP-EGmissing 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 6 0660 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

mechanism on certain CADD-Solis Pum

nearly impossible to remove the medicat

purpose of the cassette lock is to secure

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 counterweig

tightened to the required torque specifica

never occurred) this could result in the co

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 4

but the 4DITC software does not recogncouch parameters can be applied to any

isocenter definition. This involves produ

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 d

mean pressure gradient in the cardiac m

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 cr

potential for falsely elevated creatinine re

A) Endoplege Coronary Sinus Catheter, Model EPB) Steerable Coronary Sinus Catheter, Model SCS01

Edwards Lifesciences 2011-02-07 2010-12-03 60295 Type II A) EPB) SCS01

A) >10 Numbers, Contact ManufacturerB) 666556, 669235, 678238, 751043, 755821,

763122

Edwards Lifesciences is recalling the EP possible hemostasis valve displacement

in packages of these products. If the valv

that the valv e could be pushed through t

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 chan

situation in which there may be leakage

dispersive path for the patient if the unit

Bouffant Caps Trudell Medical Marketing Limited 2011-02-07 2010-08-25 56406 Type III T16199400DFL 100315 A report received to-date indicates that t

may come off in a form of tiny blue partic

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 s

(IFU) of the device to reinforce the corre

transcatheter heart valve (THV) when it i

Edwards Lifesciences has become awarunseat the valve within the loader, creati

the loader is hydrated per the IFU this lea

observed, leakage can be easily resolve

vanne dans le chargeur est hydrate selodtecte avant lutilisation. Les fuites pe

boutons de fixation si elles sont dceles

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 w

correctly. If the handle is subjected to a f

battery may shift in the c artridge. This co

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-

No safety/efficacy issues since collar i s t

A) Alaris PK Syringe Pump

B) Alaris CC Syringe Pump

C) Alaris Tiva Syringe PumpD) Alaris GH Syringe Pump

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

B) 80033UND1

C) 80043UN01D) 80023UN01



C) >10 Numbers, Contact ManufacturerD) >10 Numbers, Contact Manufacturer

CareFusion is aware of three significant

administering into a high negative (v acu

This condition may exist where the infusipumps such as extracorporeal blood pum

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 b

seal that maintains the sterility of the pro

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 D

that is causing the TAQ to not work prope

(TAQ polymerase vial lot # 864459) are

A) Agilent-Information Center

B) Agilent-Information Center Client

C) Intellivue-Information Center Client

D) Intellivue-Information CenterE) 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, M3155E) M3154

F) M3170




D) >10 Numbers, Contact ManufacturerE) >10 Numbers, Contact Manufacturer


Users have replaced keyboards supplied

keyboards which have an audio volume

to easily mute audio alarms on the Intelli

The alarm audio volume on bedside moInformation Center is not affected. Althou

warnings about the use of hardware and

that ignoring the warning can result in los

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 o

the concurrent reconstruction will fail and

lost. This may cause the customer to re-s

Cl ear-Trac Flexi ble Reusabl e Obturat ors Smit h & Nephew, Inc. , Endoscopy Div ision 2011-02-21 2011-01-13 6 0801 Type I II 72200899, 72200900, 72201796 > 10 Num bers, C ont act Manuf ac turer Smi th & Nephew has f ound that speci ficthe disposable Clear-Trac cannula ident


6/46

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

are manufactured by Triad Group and ar

concerns.

A) HMX Hematology Analyzer

B) Coulter MAXM Hematology Analyzer

C) Coulter MAXM Hematology Analyzer with Autoloader andReticulocyte

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

omit the tilde (~) character when the tilde

label scanned by the primary mode barcas '123456' with the tilde character omitt

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 tha

expected values when using the Synchro

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 co

portion of the detector arms of Preceden

resulted in the detector arms breaking. Afracture in the upper portion of the arm, w

the arm and detector to fall.

L ex i co n K Fi l es La be ll ed as Le xi con C Fi le s Den tsply Tu lsa Den ta l Spe cial t ie s

Trading as Dentsply Endodontics

2011-02-21 2011-01-17 61001 Type III CF01025 1007002395 The pack may contain drills of a differen

The Lexicon K Files have been labelled

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 SB

platform position scale markers. Also affe

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, Sanv

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 a

accurately measure glucose in some uri

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

was no or low volume of reagent in the vvolume of reagent was dispensed into da

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

connected to the bypass modules listed

TCAutomation software version 3.1.1 an

for a sample other than the intended sam

results being assigned to the wrong patie

Reliance Synergy Washer/Disinfector Steris Canada Corporation 2011-02-21 2010-10-29 58918 Type III FH03072 3612510004, 3612410008 Synergy users may occasionally experie

cycles due to t emperature reading errors

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 PackH) 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, M102282XE) 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 ManufacturerH) >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 G

initiated due to concerns expressed by t h

initiated because use of inadequately ste

StealthStation S7 - Cart Medtronic Navigation, Inc. 2011-02-21 2011-01-11 60744 Type III 9733856 4501254366 Some navigation cameras manufactured

a faulty electronic component that can ca

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 thes

A) Alaris PK Syringe Pump

B) Alaris CC Syringe Pump

C) Alaris Tiva Syringe Pump

D) Alaris GH Syringe Pump

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

B) 80033UND1

C) 80043UN01

D) 80023UN01





CareFusion is aware of three significant

administering into a high negative (v acu

This condition may exist where the infusi

cardiopulmonary bypass pumps, or haem

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 dat

the flexmap acquisition. This can cause a

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

initiate a system restart during a clinical p

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 manufact

have been produced with excess materia

intubation hoop into the down position thaccessories making it impossible to (A) p

prevent the accessories from being fully

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

calibrating with the tinaquant soluble Tra

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

lots of Therakos UVAR XTS Procedural


7/46

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 colo

OneTouch Diabetes Management Softwa

Software. This issue does not affect any

limited to OneTouch Ping Meter Remote

A) Carescape Monitor B850 System -C1 CPU

B) Carescape Monitor B850 System - C1 CPU with third v ideo

GE Medical Systems I nformation Technologies,

Inc.

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

B) 2020913-003



Numerous different problems under spec

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 co

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 exper iences internal w

alarms even though no actual fault cond

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 compl

perforation with no direct failure of the de

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

cassettes creates an image size which is

smaller than true size will be printed, or d

workstation. This will only occur when the

editing menu. Other uses are not impact

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 v alida

quantitative result (calculated value) will

transmitted to the LIS (laboratory integra

A) Custom Sterile Cystoscopy Pack

B) Custom Sterile ABDOM Hysterectomy Pack

C) Custom Bowel Resection-Lithotomy PackD) 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 PackQ) 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) SBA30BLXXXD) 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) SNE30CRXXXP) 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,ContactManufacturer/

>10Numros,Contacterle fabricant

B)>10 Numbers,ContactManufacturer/

>10Numros,Contacterle fabricantC)>10 Numbers,ContactManufacturer/


D)>10 Numbers,ContactManufacturer/


E)>10 Numbers,ContactManufacturer/


F)>10 Numbers,ContactManufacturer/


G)>10 Numbers,ContactManufacturer/


H)>10 Numbers,ContactManufacturer/


I)>10 Numbers,ContactManufacturer/


J)>10 Numbers,ContactManufacturer

K)>10 Numbers,ContactManufacturer

L)>10 Numbers,ContactManufacturer

M)>10 Numbers,ContactManufacturer

N)>10Numbers,ContactManufacturer/ O)>10Numbers,

ContactManufacturer/ P)>10 Numbers,ContactManufacturer

/Q) >10Numbers,Contact Manufacturer

R)>10 Numbers,ContactManufacturer

S)>10 Numbers,ContactManufacturer

T)>10Numbers,ContactManufacturer /U) >10Numbers,

ContactManufacturer /V) >10Numbers,Contact Manufacturer

/W) >10Numbers,Contact Manufacturer

X)>10 Numbers,ContactManufacturer

Y)>10 Numbers,ContactManufacturer/ Z)>10 Numbers,

ContactManufacturer

AA)>10 Numbers,ContactManufacturer

The Triad Sterile Lube Jelly component

by FDA regarding the validation of the ga

products. Cardinal Health Canada courieJanuary 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 sof tware def ect relating to the

digene HC2 assays on the same 96-well

identifier associated with second assay p

edited patient specimen identifier to becluminometer 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 erro

outer pouch. Although the sterility of the

inner pouch containing the product cann

could potentially cause contamination of

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 repor

prompting from the user. According to th

this independent movement can occur w

findings have led Trumpf to assume for t

movement could occur on any version of

A) Xeleris 2 Workstation Imaging System

B) Xeleris Nuclear Medicine Workstation

C) Xeleris 3 Workstation Imaging System

GE M edi cal S yst ems I srael, F uncti onal I maging 2011-03-07 2011-01-19 5 9982 Type II A) H3900JH, H 3900NM, S 8006KA/KB /KC/ KD

B) H3700JA/JB/KA/KB

C) XELERIS 3



C) 0000CZC94158R3000,

0000CZC94154WH002

1. Erroneous measurements on CT imag

standardized uptake values (SUV) 3. So

between display of early and late images

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 succesetup required an additional tube of 7 c o

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 di

is a consequence of discharge of electro

A) Lubricating JellyB) Urethral Catheterization Tray Vesical

C) Probe Installation Kit-Bladder Syringe

Om ega M ed ic al P rod uc ts 2 011 -0 3-0 7 20 11 -01 -1 1 610 42 T yp e I I A ) 1 0- 847 2, LG -105B) 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

A) >100 Numbers, Contact ManufacturerB) >100 Numbers, Contact Manufacturer


Recall initiated following an alert from Trsterilization that could result in patient inf

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, P4291B) P1851, P1881, P2451, P248, P3051, P3081, P4251, P428



Continuation of the Triad alcohol wipe re

Subcutaneous Infusion Pump (device ideSubcutaneous Infusion Set (device ident

potential contamination of the Triad Gro

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 s

bone densitometer systems is being reca

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

in the PleurX Kits. The recall of the alcoh

contamination.


8/46

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


B) >10 Numbers, Contact Manufacturer1- Increase frequency of white screen

2- Potential of unrestricted flow when

check flow stop alarm intended to wa

consistently operate as intended and

3- Reports of Symbiq Pump not detec

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

inadvertently switched and incorrectly lab

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 multion reports that some units contained dis

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 termi

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

that may manifest itself approximately 6

sticky masks could result in inconvenienc

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 fe

certain software versions of Aplio XG an

transducer PST-65AT may become abno

selected during the same study. This is

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

Inhibin A ELISA may not meet the stated

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 est

hCG kit boxes were packed with incorrectest 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

Anchor has the incorrect colour. It should

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

button, the button can become stuck und

continuous tilt movement of the system,

A) Spherasorb Carbon Dioxide AbsorbentB) Loflosorb

C) Intersorb Plus

Intersurgical Incorporated 2011-03-07 2011-01-28 61370 Type II A) 2196, 2197B) 2198

C) 2194, 2195

A) 1100392, 1101241, 1101426B) 1101107, 1101427, 1101428

C) 1101240, 1101423, 1101902, 1102596

Possibility that loose granules may enterapplies only to GE-ADU and Anmedic Q

Continuous Flush Device 55UF130 Edwards Lifesciences LLC 2011-03-07 2010-09-29 60283 Type III 55UF130 58495701, 58480446 Edwards Lifesciences discovered that th

the box (case) label as 3 ml/hr, but was c

This error was limited to the two lots state

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 classif

Canada, it was determined that this devi

therefore considered invasive and should

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 valu

interchangeably (unexpectedly or random

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 cerv

VCare vaginal-cervical ahluwalia's retrac

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 b

may represent a potential health hazard

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 f

serial number band of detector holders h

the detector holder's arm the aff ected de

Aria Radiation Oncology

Updated recall # 57958 previously posted on

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, H466058A behavior seen with Varian Treatmen

Siemens Linear Accelerator using Dig

in delivery of a conventional or IMRT

installed with the couch value propag

couch rotation values were updated f

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 receive

time displayed on the Architect when usi

01110L000 onto the Architect and scannboard stability of 1680 hours, which wou

is 168 hours, which would equal 7 days.

2152/R1) states in the storage instructio

reagent kit may be stored on board the A

conversion of 7 days into hours is 168 ho

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 ha

leaks for Optiflux F250NRe Hemodialyze

revealed that lot 10HU02012 demonstra

and following lot 10HU02012. Same thin

10LU2016.

Maxcem Elite Kerr Corporation 2011-03-21 2011-02-21 61829 Type III 34418 3360900 Complaint received that set time for Max

restoration was placed on tooth it would

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 Cla

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 Re

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 issu

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)

causing pressure and vacuum error.


9/46

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 fragme

a result of a catheter break, catheter she

remove unused catheter. / Migrations de

pourraient se loger dans lespace intrathcathter ou de la dcision dun mdecin d

External Pulse Generators Medtronic Inc. 2011-03-21 2010-10-15 59975 Type II 5388 >10 Numbers, Contact Manufacturer Model 5388 Dual-Chamber External Tem

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 custom

access thyroglobulin antibody II (TGAB)

A) Gen-S Analyzer

B) Coulter LH 780 Hematology Analyzer

C) Coulter LH 750 Hematology Analyzer

D) Coulter LH 500 Hematology Analyzer

Beckman Coulter, Inc. 2011-03-21 2011-01-30 61367 Type II A) 6605381

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 fiel

year is greater than 2010.

Issue 2: If the 1G1 transmission format is

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 tren

cold welding to the drill guide causing the

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 con

B1A128 may produce false positive resu

patient's sample. Three lots of INSTI wer

from lot B1A28: B1A135, B1A136, B1A1

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 reGroup. That recall is due to concern by t

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, Smiths Medical has become aware of an

on certain sets. In some cases, the kink m

patient. A reduction in flow rate may lead

injury or death. / La socit Smiths Medic

rapports sur les problmes de tortillemen

Dans certains cas, ces conditions peuve

administr au patient. La rduction du d

thrapie et causer des blessures au patie

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 in itiated due to con

Administration regarding the validation o

was initiated because use of inadequate

/ Le prsent rappel a t amorc la suit

Administration au sujet de la validation d

car lutilisation de tout produit dont la st

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 volu

VP07 to VP08 in models 203 and 203a. T

and a number of minor items recently ide

analysis. / La socit Bunnell Incorporat

une mise niveau du logiciel de lapparela version VP07 la version VP08. La m

problmes principaux et un certain nomb

identifis dans le cadre dune analyse ind

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 expdevice to malfunction and the led will sta

et de modle Lucas 2 ont prsent des pdu type couvercle, ce qui entrane le fonc

clignotement des DEL de lafficheur.

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 m

and in remote instances, the system may

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

Analysis System: 1. Specimen tubes ma

inverts the cassette in the mixi ng station

2. The DXH 800 may fail to meet the car

when the WBC is greater than 70 x 103 c

to meet the carryover specification for NR

cells/ul (50 x 109 cells/l). 4. The handheusing 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 proble2681530k, 2661580k). The Unicel DXHT

the error message 'XML parsing error' wh

prior to analysis. An additional character

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 T

recalled product manufactured by Unommasks is that there could be a sticky sub

may manifest itself i n approximately 6 to

sticky masks could result in inconvenienc

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 mo

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 spec

the potential presence of small metal de

may have accumulated during the manu

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 osmolal

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 driv


10/46

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

delivery due to a kinked/bent cannula. T

functionality of the infusion set and poten

unnoticed, it can result in elevation of blo

Acticlot dPT American Diagnostica Inc. 2011-03-21 2011-03-03 61637 Type II 824 101028 Testing has revealed a stability issue tha

Based upon testing, we have revised the

"on-board" rehydrated stability of the dPT

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 sup

the electrical board & line voltage, which

caregiver.

A) T.E.S.S. - I nsert 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 P

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

A) All Serial Numbers

B) All Serial Numbers

Hospira has received customer reports o

alarm conditions, which have been asso

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 comp

cardioplegia table line when negative pre

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 comp

cardioplegia table line when negative pre

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

such that the device fragments stones at

A) Orbit 90 Subcutaneous Infusion SetB) 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) >10 Numbers, Contact ManufacturerB) >10 Numbers, Contact Manufacturer

A small percentage of devices may becobecome bent and/or the needle sheath to

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

Review Station (CRS) were not reflected

reports. This occurred when echocardiog

correctly within the CRS persistence data

when point-trace mode was enabled in CA software upgrade to CRS 2.14.03.SU2

A) Accu-Chek Inform II Meter

B) Accu-Chek Inform II + RF Meter

Roche Diagnostics GMBH 2011-03-21 2011-02-15 61885 Type II A) 05060311001

B) 05060303001

A) UU11038344, UU11006762, UU11006763,

UU11006766, UU12005334


Unexpected change in the configuration

Inform II RF Meters caused by a l oss of f

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

results to be generated. The erroneous r

and may occur without i nstrument gener

average probability of occurrence of erro

aspiration of a specimen tube of 0.6% wi

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

plasma P has been found out of range d

Therefore, patient results cannot be relea

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

circuits are first inserted into the main un

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 p

correction initiated by triad group, who s

was initiated by triad group due to conce

prep pads. If contaminated alcohol prep

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 treatm

targets resulting in potential under dose.

issue are sharp dose gradients with few,

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 H

become unstable when used in conjuncti

that exceed the weight and moment limitorientation of these devices may result in

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 tha

error without Health Canada compliance

or special access provisions of the medic

devices included instructions for use app

balloon configuration of the subject devic

BD Nokor Vented Needle Becton Dickinson 2011-04-04 2011-03-02 62125 Type III 305213 0007829 One lot of the vented needle (305213) wthe non vented needle (305216) top web

and shelf carton were labelled properly w

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 rec

subsequently prevent those from overhe

attached to the connections identified as

Precinorm PUC Roche Diagnostics GMBH 2011-04-04 2011-02-16 61881 Type III 03121313122 157086 Labelling error since the wrong version oPrecinorm 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 in

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 du

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 lab

report of customer receiving 65652-124

number 1091745 manufactured 11/16/20

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 measuremen

Reusable Sensor may incorrectly measu

spot check pulse co-oximeter may provid


11/46

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 Synch

refill procedure.

Precipost DT Hospira Inc. 2011-04-04 2011-02-15 61913 Type I 11005 All Serial numbers Hospira has received customer reports o

alarm conditions, which have been asso

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

2 011 -0 4-0 4 20 11 -02 -1 7 621 37 T yp e I II A ) 1 10 -01 99G 2, 110- 01 99G 4, 110- 02 34G 3

B) 51050161WW, 51050181WW

C) P9200DDE, P9200DDEC, P9212DDE

A) N/A

B) N/A

C) N/A

There is an anomaly in the firmware whic

high network traffic that can distort the di

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 o

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 earl ier than V1.3.1.0 Rad-8 devices have been noted to rever

despite the user having configured the d

Haemophilus ID Quad Remel Inc. 2011-04-04 2011-02-25 61992 Type II RE02460 982564 Incorrect expiry date printed on outside b

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 (ampe

the glucose and lactate sensors during p

results with potentially severe impacts to

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

batteries should not be used with t he INF

of this new communication is to i nform c

system, uses the same size battery and i

and, that other brands of C-size alkaline inhibits electrical contact.

A) DePuy Cement Restrictor

B) DePuy Cement Restrictor (Universal)

DePuy Ort hopaedic s, I nc. 2011-04-04 2011-03-08 6 2231 Type I II 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

regarding a packaging issue (recall num

identified that, due to an administrative e

applications had not been filed with Hea

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

regarding a packaging issue (recall numidentified that, due to an administrative e

applications had not been filed with Hea

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 cer ta in models o

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

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 imag

transmission of end of treatment data fro

information is prioritized and the end of t

system. This leads to a potentially misleain 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 Dias

certain cooling modules. The affected co

result heat generated by the Peltier (ther

not be properly dissipated. The heat buil

cooling module. Failure of the cooling m

analyzer reagent area to exceed allowab

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

Heavy use of prosthetic may result in pa

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 li

interpretation analysis method and the m

software. The user will not be able to getHLA typing results will be given f or DRB

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 bee

The listed products, used for HLA typing

(probes and primers) used in manufactu

practice. For previously assigned HLA ty

review and confirm the results using an a

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 prod

pliable and would be difficult to use for in

fold over in the narrower areas of assem

process and informed King Systems on J

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

Cobas Integra Calcium Roche Diagnostics GMBH 2011-04-04 2011-03-03 62097 Type II 20763128322 630204-01 Imprecision and erroneous patient result

to a lesser extend on Cobas C501 system

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 re

displayed values could be drifting or inac

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 i

treatment field. Varian has received rep

focus, and have proceeded to delete MLC

in the mistaken belief they were acting o

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 se

unexpectedly, if preventive maintenance

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 r

times not being able to reset the alarm to

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 som

instrumentation, and hygiene systems) t

the dental chair.


12/46

A) HMX Hematology Analyzer

B) Coulter LH 500 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

chips have been found in LH500 and HM

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 J anuary 2008

B) All lots since J anuary 2008

The alcohol prep pads contained in the k

Electric Bed Model FLH668NDCM Stryker Medical 2011-04-18 2011-03-09 62221 Type II FLH668NDCM All lots Stryker Medical has become aware that

Bertec Medical] has the potential for eith

drop unexpectedly, if preventive mainten

owner's manual.

Cobas 4800 - Cobas X480 Module Roche Molecular Systems, Inc. 2011-04-18 2011-03-10 62268 Type II 0520089

md recalls 2011-eng

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