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Drugs and Health Products
Medical Device Recall Listings - Sorted by Trade Name
(From April 2009 - June 2009)
- Trade Name
- 09-0142, Dean Scissors
- Recall Posting Date
- 2009-05-25
- Manufacturer
- Walter Lorenz Surgical, Inc. Also Trading As: Biomet Microfixation
- Recall Start Date
- 2009-04-02
- Recall Number
- 47701
- Hazard Classification
- Type II
- Model or Catalog #
- 09-0142
- Lot or Serial #
- >10 Numbers, Contact Manufacturer
- Reason for Recall
- The 09-0142, Dean Scissors are breaking when used.
- Trade Name
- 1.5T Signa Infinity MR Excite - System
- Recall Posting Date
- 2009-06-22
- Manufacturer
- GE Healthcare
- Recall Start Date
- 2009-05-11
- Recall Number
- 47837
- Hazard Classification
- Type II
- Model or Catalog #
- 2294302, M3000CB
- Lot or Serial #
- > 10 Numbers, Contact Manufactuer
- Reason for Recall
- An error in the coding of the 11.1_M4_0818A version of software can result in images being flipped under very limited and specific conditions.
- Trade Name
- 1550 Electric Stetcher With Quick Drop
- Recall Posting Date
- 2009-04-13
- Manufacturer
- Stryker Medical
- Recall Start Date
- 2009-03-16
- Recall Number
- 47353
- Hazard Classification
- Type II
- Model or Catalog #
- 1550-000-000
- Lot or Serial #
- > 100 Numbers, Contact Manufacturer
- Reason for Recall
- Stretcher fowlers (backrests) may develop a grinding noise from wear of drive nut threads in the fowler. If the stretcher continues to be used, the fowler may inadvertently drop to its lowest (flat) position.
- Trade Name
- 2.7mm Cortical Screw Self-Tapping
- Recall Posting Date
- 2009-06-22
- Manufacturer
- Zimmer Inc.
- Recall Start Date
- 2009-06-01
- Recall Number
- 48914
- Hazard Classification
- Type II
- Model or Catalog #
- 00-4827-024-01
- Lot or Serial #
- 60886890
- Reason for Recall
- The 2.7mm Cortical Screw Self-Tapping package could potentially hold the 4.0mm cancellous screw partially threaded (part number 00-4840-022-01).
- Trade Name
- 5/0 Polyglycolic Acid Absorbable Suture
- Recall Posting Date
- 2009-04-13
- Manufacturer
- Ace Surgical Supply Co. Inc.
- Recall Start Date
- 2009-02-24
- Recall Number
- 47393
- Hazard Classification
- Type II
- Model or Catalog #
- 34630
- Lot or Serial #
- 081031-07
- Reason for Recall
- A small and limited number of packaged product demonstrated a partial delamination, or coming apart, of the two layers of material that make up the clear portion of the outer packaging.
- Trade Name
- A) Achieva 3.0T MRI System-Main Unit
B) Achieva 1.5T MRI System-Main Unit - Recall Posting Date
- 2009-06-22
- Manufacturer
- Philips Medical Systems Nederland B.V.
- Recall Start Date
- 2009-06-09
- Recall Number
- 49149
- Hazard Classification
- Type II
- Model or Catalog #
- A) ACHIEVA 3.0T
B) ACHIEVA 1.5T - Lot or Serial #
- A) N/A
B) N/A - Reason for Recall
- The affected MR accessory carts may contain magnetic material and can therefore be attracted to the magnet.
- Trade Name
- A) Acuson Sequoia 512 Ultrasound System
B) Acuson Sequoia C512 Echocardiography System
C) Acuson Sequoia C512 Echocardiography System
D) Acuson Sequoia 512 Ultrasound - Recall Posting Date
- 2009-05-25
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Recall Start Date
- 2009-04-02
- Recall Number
- 47909
- Hazard Classification
- Type III
- Model or Catalog #
- A) 82 45 875
B) 8255412, 8267697
C) 10038242
D) 10038241 - Lot or Serial #
- A) 53736, 54558, 55331, 61377, 63210
B) 53418, 57395
C) 68153, 68211, 68217, 68328, 68330, 68335, 68365, 68366, 68368, 69281, 69291
D) 68444, 65685 - Reason for Recall
- To inform our customers of a potential software problem with the Acuson Sequoia Ultrasound System that may result in overheating of the auxiliary 2 mHz continuous wave (CW) transducer.
- Trade Name
- A) Alaris PC Unit
B) Alaris PCA Module - Recall Posting Date
- 2009-05-11
- Manufacturer
- Cardinal Health 303, Inc.
- Recall Start Date
- 2009-03-10
- Recall Number
- 47844
- Hazard Classification
- Type III
- Model or Catalog #
- A) 8015
B) 8120 - Lot or Serial #
- A) >1000 Numbers, Contact Manufacturer
B) >1000 Numbers, Contact Manufacturer - Reason for Recall
- Potential risk when the Alaris PCA Module is used with the Alaris PC Unit. The Alaris PCA Module can potentially infuse above or below the intended infusion dose for a specific sequence of events.
- Trade Name
- A) Artiste Syngo RT Therapist Assist
B) Artiste Syngo RT Therapist - Recall Posting Date
- 2009-05-25
- Manufacturer
- Siemens Medical Solutions USA, Inc.
Oncology Care Systems - Recall Start Date
- 2009-04-21
- Recall Number
- 48254
- Hazard Classification
- Type III
- Model or Catalog #
- A) 08162807
B) 08162815 - Lot or Serial #
- A) 10024
B) 10040 - Reason for Recall
- When all plans are loaded on the device, if the beam plan is edited, accessory information in the lantis can be potentially overwritten or removed, could result in mistreatment on another linear accelerator.
- Trade Name
- A) Avalon Fetal Monitor FM30-Main Unit
B) Avalon Fetal Monitor FM20-Main Unit - Recall Posting Date
- 2009-06-22
- Manufacturer
- Philips Medizin Systeme Boeblingen GMBH
- Recall Start Date
- 2009-06-09
- Recall Number
- 49150
- Hazard Classification
- Type II
- Model or Catalog #
- A) M2703A
B) M2702A - Lot or Serial #
- A) DE53001002 Through DE53107383
B) DE53001002 Through DE53107383 - Reason for Recall
- This problem affects revision C and D of the software. In rare circumstances, the settings for paper scale type and recorder speed may revert back to the factory default settings, which are: USA paper style and 3 cm/min paper speed. This behaviour would have the most impact in Europe and Asia/Pacific where other settings are preferred. If this change remains undetected by the user, it may lead to misinterpretation of the fetal trace and potential incorrect clinical decisions regarding patient care. The problem occurs when the power-up/boot sequence of the fetal monitor is interrupted, e.g. switching the monitor off or unplugging the power cord before it has completed the boot sequence and switching it on again immediately (within 60 sec) after the interruption.
- Trade Name
- A) Cell-Dyn 3700 SL Analyzer
B) Cell-Dyn 3700 CS Analyzer - Recall Posting Date
- 2009-04-27
- Manufacturer
- Abbott Laboratories Diagnostic Division
- Recall Start Date
- 2009-04-01
- Recall Number
- 47694
- Hazard Classification
- Type III
- Model or Catalog #
- A) 02H31-01
B) 02H30-01 - Lot or Serial #
- A) All Serial Numbers
B) All Serial Numbers - Reason for Recall
- There have been occurrences of visible fire and smoke from the analyzer. They may contain the incorrect fuse for the electrical configuration at the customer site.
- Trade Name
- A) Cognis CRT-D HE
B) Cognis CRT-D
C) Teligen ICD (VR-HE DF1)
D) Teligen ICD (DR-HE IS-1) - Recall Posting Date
- 2009-04-27
- Manufacturer
- Cardiac Pacemakers Incorporated
- Recall Start Date
- 2009-04-03
- Recall Number
- 47936
- Hazard Classification
- Type II
- Model or Catalog #
- A) N106
B) N107
C) E102
D) E110 - Lot or Serial #
- A) N/A
B) N/A
C) N/A
D) N/A - Reason for Recall
- Right ventricular lead complications may cause additional over-sensing ,thereby increasing the probability of inappropriate therapy.
- Trade Name
- A) Combi Sling
B) Combi Sling Deluxe Child
C) Combi Sling Mesh Deluxe Child
D) Combi Sling Deluxe Oversize
E) Combi Sling Mesh Deluxe Oversize
F) Combi Sling Oversize Heavy Duty
G) Combi Sling Mesh Deluxe - Recall Posting Date
- 2009-04-27
- Manufacturer
- BHM Medical Inc.
- Recall Start Date
- 2009-04-03
- Recall Number
- 47789
- Hazard Classification
- Type II
- Model or Catalog #
- A) 626002
B) 626002C
C) 626002C-M
D) 626003
E) 626003M
F) 626003X
G) 626002M - Lot or Serial #
- A) N/A
B) N/A
C) N/A
D) N/A
E) N/A
F) N/A
G) N/A - Reason for Recall
- A premature failure of the stitching at the junction of the shoulder strap and the sling body can lead to the detachment of the shoulder strap resulting in possible patient fall.
- Trade Name
- A) Contak Renewal 4 CRT-D
B) Vitality 2 Acid - Recall Posting Date
- 2009-05-11
- Manufacturer
- Cardiac Pacemakers Incorporated
- Recall Start Date
- 2009-03-04
- Recall Number
- 47031
- Hazard Classification
- Type II
- Model or Catalog #
- A) H-190, H-197, H-199
B) T165, T167, T175, T177 - Lot or Serial #
- A) N/A
B) N/A - Reason for Recall
- Potential for reduced ERI to EOL time in a subset of implantable defibrillators, due to degradation of a low-voltage capacitor.
- Trade Name
- A) Discovery X-Ray Bone Densitometer
B) Explorer X-Ray Bone Densitometer - Recall Posting Date
- 2009-05-11
- Manufacturer
- Hologic, Inc.
- Recall Start Date
- 2009-04-17
- Recall Number
- 47998
- Hazard Classification
- Type II
- Model or Catalog #
- A) DISCOVERY-A, DISCOVERY-C, DISCOVERY-CI, DISCOVERY-W, DISCOVERY-WI
B) EXPLORER - Lot or Serial #
- A) S/N: 83232, 83336, 83760, 83792, 83024, 82888, 83053, 83318, 83576
B) SN 91129 - Reason for Recall
- In rare instances, the system does not turn the x-rays off at the end of a DXA scan. The "x-ray on" indicator light remains on, but an audible signal and the computer screen indicate the x-ray is off.
- Trade Name
- A) E300 Corneal Topographer
B) DV2000 Digital Imaging Software
C) M700 Automated Perimeter - Recall Posting Date
- 2009-05-11
- Manufacturer
- Medmont PTY Ltd.
- Recall Start Date
- 2009-03-10
- Recall Number
- 45746
- Hazard Classification
- Type II
- Model or Catalog #
- A) N/A
B) N/A
C) M700 - Lot or Serial #
- A) >10 Numbers, Contact Manufacturer
B) >10 Numbers, Contact Manufacturer
C) >10 Numbers, Contact Manufacturer - Reason for Recall
- Unlicensed class II medical device.
- Trade Name
- A) Endopath Endoscopic Linear Cutters
B) Endopath Endoscopic Linear Cutters
C) Endopath Endoscopic Linear Cutters - Recall Posting Date
- 2009-05-11
- Manufacturer
- Ethicon Endo-Surgery, LLC
- Recall Start Date
- 2009-04-08
- Recall Number
- 47966
- Hazard Classification
- Type II
- Model or Catalog #
- A) LONG45A
B) ATB45, ATW45
C) NAW45 - Lot or Serial #
- A) E4MM23, E4MP4A, E4MT4Y
B) E4MH2L, E4MG9M, E4ML6J, E4MH18
C) E4MJ3K, F4MX8C, F4N799 - Reason for Recall
- The mechanism which connects the articulation joint to the device shaft may be insufficient. This may cause the jaws of some of the affected Endoscopic Linear Cutters to remain closed and clamped down on tissue.
- Trade Name
- A) Grieshaber Handpiece, MPC Microscissors
B) Vertical Scissors - Recall Posting Date
- 2009-04-27
- Manufacturer
- Alcon Grieshabe AG
- Recall Start Date
- 2009-04-06
- Recall Number
- 47782
- Hazard Classification
- Type II
- Model or Catalog #
- A) 705.52
B) 704.52 - Lot or Serial #
- A) F53125, F58670, F65194, F67471, F69429
B) F61426, F63004 - Reason for Recall
- New metal cannula assemblies are scheduled for launch in June 2009. These new metal cannula may have a tolerance stack up issue with selected lots of these scissors.
- Trade Name
- A) Heparin pre-filled syringes
B) Saline pre-filled syringes - Recall Posting Date
- 2009-04-13
- Manufacturer
- Medxl Inc.
- Recall Start Date
- 2009-03-29
- Recall Number
- 47632
- Hazard Classification
- Type II
- Model or Catalog #
- A) 3706, 3780, 3781, 3786, 3787
B) 3704, 37043, 37043B, 37043BNC, 3705C, 3705NC, 3706 - Lot or Serial #
- A) All lots between 6892 and 8180
B) All lots between 6892 and 8180 - Reason for Recall
- Complaints received about discolouration and particulate matter contamination.
- Trade Name
- A) Integris V5000/BV5000
B) Integris H5000F Cardiology Imaging System
C) Integris H5000C Cardiology Imaging System
D) Integris BH5000 Cardiology Imaging System
E) Integris Allura
F) Allura XPER FD10
G) Integris H1000
H) Integris H3000
I) Integris V3000 - Recall Posting Date
- 2009-06-22
- Manufacturer
- Philips Medical Systems Nederland B.V.
- Recall Start Date
- 2009-05-12
- Recall Number
- 49048
- Hazard Classification
- Type II
- Model or Catalog #
- A) 722041*, 722042*
B) 722017
C) 722016
D) 722021
E) 722043*, 722044*
F) ALLURA XPER FD10
G) N/A
H) N/A
I) N/A - Lot or Serial #
- A) N/A
B) N/A
C) N/A
D) N/A
E) N/A
F) N/A
G) N/A
H) N/A
I) N/A - Reason for Recall
- A partial grid switch failure may occur in Allura XPER and Integris systems that may result in a higher x-ray dose than expected. This issue may pose a risk for patients or users. The potential failure can lead to a radiation exposure rate in excess of the 11.5 R/min Health Canada requirement. However, it will only occur if the grid switch fails during fluoroscopy examinations using high KV values.
- Trade Name
- A) IV Set with Universal Spike, 2 Ultrasite
B) Primary IV Set with 3 Ultrasite - Recall Posting Date
- 2009-04-27
- Manufacturer
- B. Braun Medical Inc.
- Recall Start Date
- 2009-03-27
- Recall Number
- 47750
- Hazard Classification
- Type II
- Model or Catalog #
- A) 352049/CSP152VSL
B) 352049, 375100 - Lot or Serial #
- A) 61028769, 61028767
B) 61029904, 61029908 - Reason for Recall
- Investigation for occlusion/no flow identified that disks involved in the low pressure check valve to have not been polyisoprene coated.
- Trade Name
- A) MANTIS Rod Inserter
B) MANTIS Rod Inserter Inner Shaft - Recall Posting Date
- 2009-06-08
- Manufacturer
- Stryker Spine SAS
- Recall Start Date
- 2009-04-28
- Recall Number
- 48210
- Hazard Classification
- Type II
- Model or Catalog #
- A) 48284050
B) 48284051 - Lot or Serial #
- A) All Lot Numbers
B) All Lot Numbers - Reason for Recall
- The stainless steel split sphere in the Mantis Rod Inserter Shaft has the potential to become deformed when subjected to high force. Once deformed, the split sphere may separate from the shaft.
- Trade Name
- A) Multidiagnost Eleva-Flat Detector
B) Allura XPER FD10/10-Main Unit - Recall Posting Date
- 2009-06-22
- Manufacturer
- Philips Medical Systems Nederland B.V.
- Recall Start Date
- 2009-05-15
- Recall Number
- 48595
- Hazard Classification
- Type II
- Model or Catalog #
- A) 70834
B) ALLURA XPER FD10/10 - Lot or Serial #
- A) N/A
B) N/A - Reason for Recall
- The system may shut down and not restart due to a manufacturing error in the printed circuit board in the main-cabinet.
- Trade Name
- A) Nexgen LPS
B) Nexgen LPS-Flex Femoral Components - Recall Posting Date
- 2009-05-25
- Manufacturer
- Zimmer Inc.
- Recall Start Date
- 2009-04-23
- Recall Number
- 48206
- Hazard Classification
- Type II
- Model or Catalog #
- A) 00-5964-014-51, 00-5964-017-51
B) 00599601451 - Lot or Serial #
- A) 61219714, 61204820
B) 61207901 - Reason for Recall
- These items may possess a nonconforming finish on the polished surfaces which could potentially increase wear and decrease the product life cycle on the articulated surface.
- Trade Name
- A) Option + Sterile PADS 5cm X 5cm
B) Option + Steriles PADS 10cmX10cm - Recall Posting Date
- 2009-04-13
- Manufacturer
- Uniprix Inc.
- Recall Start Date
- 2009-03-13
- Recall Number
- 47475
- Hazard Classification
- Type III
- Model or Catalog #
- A) 771290064484
B) 771290064491 - Lot or Serial #
- A) 10380, 10381
B) 10381 - Reason for Recall
- Some sterile pads that had not been sterilized were released for sale.
- Trade Name
- A) Percutaneous Sheath Procedural Kits
B) Central Venous Catheterization Set/Kit
C) Temporary Pacing Catheter
D) Two-lumen Central Catheterization Kit
E) Percutaneous Sheath Introducer Sets
F) Stopcocks
G) Arterial Access Products
H) Thrombolic Device Rotator Drive Unit
I) Tretorola Percutaneous Thombolic Device
J) Percutaneous Sheath Introducer
K) Super Arrow-Flex Percut Sheath Intro
L) Stopcock with Luer Lock
M) Stopcock Manifold
N) Multi-Lumen Percut Sheath Introducer
O) Stopcock with Luer Lock
P) Stopcock with Luer Lock
Q) Blood Administration Sets
R) Extension Sets
S) Trerotola Percut. Thrombolytic Kit - Recall Posting Date
- 2009-04-13
- Manufacturer
- Arrow International, Inc.
- Recall Start Date
- 2009-02-18
- Recall Number
- 46908
- Hazard Classification
- Type II
- Model or Catalog #
- A) AK-09903-J, CA-09803, CA-09886, CA-09903-LF, RV-09803, SB-09803, SB-09883-S, SB-09907-S,
SP-09801
B) AK-14703-J, AM-15703-J
C) AI-06210-IK, AI-7155-IK
D) AK-17702-J
E) CL-07011, CL-07024, CL-07045, CL-07065, CL-07080, CL-071165, CL-071180, CL-07511, CL-07524, CL-07545, CL-07590, CL-07611, CL-07624, CL-07635, CL-07645, CL-07665, CL-07690, CL-07700, CL-07711, CL-07724, CL-07735, CL-07745, CL-07765, CL-07780, CL-07790-R, CL-07800, CL-07824, CL-07835, CL-07845, CL-07880, CL-07924, CL-07965, CL-07980, CP-07011, CP-07511, CP-07611, CP-07711, CP-07811, CP-07911, CR-07645, CR-07745
F) SC-00001, W-15549, W-19922
G) AA-00611, AA-15511, AA-15511-S, AA-15611, AA-15611-S, AA-15624
H) PT-65509-HFC
I) PT-45509
J) CA-09801, CA-09807, MTO-09801-CHA
K) CL-08403, CL-08503, CL-08503-A, CL-08603, CL-08605, CL-08605-HF, CL-08703, CL-08705-HF, CL-08803, CP-08403, CP-08503, CP-08603, CP-08603-P, CP-08703, CP-08803, CP-08903, CW-08703, CW-08803, IC-09880
L) W20041
M) W-20267
N) CA-11142, SI-11142
O) W19910
P) W20027
Q) W20949
R) W20042
S) PT-12709-WC, PT-65709-WC - Lot or Serial #
- A) Contact Manufacturer
B) Contact Manufacturer
C) Contact Manufacturer
D) Contact Manufacturer
E) Contact Manufacturer
F) Contact Manufacturer
G) Contact Manufacturer
H) Contact Manufacturer
I) Contact Manufacturer
J) Contact Manufacturer
K) Contact Manufacturer
L) Contact Manufacturer
M) Contact Manufacturer
N) Contact Manufacturer
O) Contact Manufacturer
P) Contact Manufacturer
Q) Contact Manufacturer
R) Contact Manufacturer
S) Contact Manufacturer - Reason for Recall
- Material used in the manufacture of these products is not lipid resistant and could be weakened during the administration of lipid solution.
- Trade Name
- A) Picis OR Manager
B) Picis Preop Manager
C) Picis Anesthesia Manager
D) Picis PACU Manager
E) Picis Critical Care Manager - Recall Posting Date
- 2009-06-22
- Manufacturer
- Picis Inc.
- Recall Start Date
- 2009-04-08
- Recall Number
- 48937
- Hazard Classification
- Type II
- Model or Catalog #
- A) model/catalog # 4235
B) model/catalog # 4250
C) model/catalog # 4220
D) model/catalog # 4245
E) model/catalog # 1110 - Lot or Serial #
- A) N/A
B) N/A
C) N/A
D) N/A
E) N/A - Reason for Recall
- If not properly configured, software will allow patient allergy and precaution data to be overwritten with automatic updates from the hospital information system (HIS). This can result in deletion of allergy information.
- Trade Name
- A) Precicontrol Cardiac
B) Precicontrol Cardiac II - Recall Posting Date
- 2009-06-08
- Manufacturer
- Roche Diagnostics GMBH
- Recall Start Date
- 2009-03-26
- Recall Number
- 47413
- Hazard Classification
- Type III
- Model or Catalog #
- A) 03530477190
B) 04917049190 - Lot or Serial #
- A) N/A
B) N/A - Reason for Recall
- Potential for precision issue with the Elecsys Cardiac and Cardiac II. Specifications for the intra-assay precision was not met independent of the Elecsys Digoxin Reagent or Precicontrol lot used.
- Trade Name
- A) Pumps/Sequential Circulators
B) BioComfort Arm Garments
C) BioComfort Leg Garments - Recall Posting Date
- 2009-06-08
- Manufacturer
- Bio Compression Systems
- Recall Start Date
- 2009-05-11
- Recall Number
- 48425
- Hazard Classification
- Type III
- Model or Catalog #
- A) SC-2004, SC-3004, SC-3008
B) GS-3035-M, GS-3035-S
C) GS-3045-H, GS-3045-L, GS-3045-M,
GS-3045-S - Lot or Serial #
- A) N/A
B) N/A
C) N/A - Reason for Recall
- Medical devices sold in Canada by Bio Compression Systems are not licenced in accordance with the medical devices regulations.
- Trade Name
- A) Sigma Pacemaker System
B) Kappa 600 KDR Series Pacemakers
C) Kappa 700 KDR Series Pacemakers
D) Kappa 700 KD Series Pacemakers
E) Kappa 700 KSR Series Pacemakers
F) Kappa 900 KSR Series Pacemakers - Recall Posting Date
- 2009-06-08
- Manufacturer
- Medtronic Inc.
- Recall Start Date
- 2009-05-18
- Recall Number
- 48540
- Hazard Classification
- Type I
- Model or Catalog #
- A) SD203, SD303, SDR203, SDR303, SDR306, SS106, SS203, SS303, SSR203, SSR303, SSR306, SVDD303,
SVVI103
B) KDR603
C) KDR703, KDR706, KDR721
D) KD701, KD703, KD706
E) KSR701, KSR703, KSR706
F) KSR903 - Lot or Serial #
- A) >100 Lots, Contact Manufacturer
B) PHH620224S, PHH620227S
C) PGY623319S, PGY623323S, PGY623355S, PGW621053S, PGR625317S, PGR625959S
D) >10 Lots, Contact Manufacturer
E) >1000 Lots, Contact Manufacturer
F) >100 Lots, Contact Manufacturer - Reason for Recall
- The pacemakers may fail at a higher than expected rate due to separation of wires that connect the electronic circuit to other pacemaker components (e.g. battery, connector). This may present clinically as loss of rate response, premature battery depletion, loss of telemetry, or no output.
- Trade Name
- A) Somatom Definition
B) Somatom Definition AS - Recall Posting Date
- 2009-05-11
- Manufacturer
- Siemens AG
- Recall Start Date
- 2009-04-14
- Recall Number
- 47910
- Hazard Classification
- Type III
- Model or Catalog #
- A) 77 40 769
B) 8098027 - Lot or Serial #
- A) 60148, 60199, 60206, 60235, 60332, 60348, 60422
B) 64032, 64049, 64052, 64069, 64137, 64141, 64233, 64238, 64306, 64316 - Reason for Recall
- Update the software on bugfixes (i-triggered sequence, bolus monitoring, 3D recon, reconstruction of raw data, 3D intervention, patient delete, AW hangup), kernel changes, graphic driver, and Microsoft hotfix.
- Trade Name
- A) Sterrad 50 Sterilizer System
B) Sterrad NX Sterilizer System - Recall Posting Date
- 2009-04-27
- Manufacturer
- Advanced Sterilization Products, A Division Of Ethicon
- Recall Start Date
- 2009-03-13
- Recall Number
- 47825
- Hazard Classification
- Type II
- Model or Catalog #
- A) 10050
B) 10033 - Lot or Serial #
- A) > 10 Numbers, Contact Manufacturer
B) > 10 Numbers, Contact Manufacturer - Reason for Recall
- The Sterrad 50 system may potentially have defective oil fill plugs. Degradation of the nylon 6-6 plugs over time, if exposed to hydrogen peroxide, can contribute to emission of oil mist from the sterilizer.
- Trade Name
- A) Symbia T/T2/T6/T16
B) Symbia S - Recall Posting Date
- 2009-05-25
- Manufacturer
- Siemens Medical Solutions USA, Inc.
Molecular Imaging Group - Recall Start Date
- 2009-03-04
- Recall Number
- 47070
- Hazard Classification
- Type III
- Model or Catalog #
- A) 08717733, 10275007, 10275008, 10275009, 10275010
B) 08717741 - Lot or Serial #
- A) 1103, 1128, 1150, 1153, 1193, 1199, 1018, 1026, 1058, 1056, 1024, 1012
B) 1143, 1112, 1159 - Reason for Recall
- Possibility a patient injury can occur when the patient is lying on the patient bed and the automatic collimator changer is undergoing a collimator change operation even when the patient bed is retracted.
- Trade Name
- A) Syngo Dynamics SD 6.0 Server Software
B) Syngo Dynamics SD 6.0 Workstation Software - Recall Posting Date
- 2009-04-27
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Recall Start Date
- 2009-02-03
- Recall Number
- 46562
- Hazard Classification
- Type III
- Model or Catalog #
- A) 100 90 370, 100 90 480
B) 100 90 257 - Lot or Serial #
- A) 95243, 92241, 95248, 93901
B) 93477 - Reason for Recall
- There is potential issue in the syngo Dynamics 6.0 reporting system. Under certain circumstances, when editing text in a report, it may result in additional phrases not populating as expected.
- Trade Name
- A) Tilt/Elevating Seating System
B) Tilt/Elevate/Recline Seating System - Recall Posting Date
- 2009-05-25
- Manufacturer
- Motion Concepts LP
- Recall Start Date
- 2009-02-19
- Recall Number
- 46283
- Hazard Classification
- Type II
- Model or Catalog #
- A) N/A
B) N/A - Lot or Serial #
- A) >10 Numbers, Contact Manufacturer
B) >10 Numbers, Contact Manufacturer - Reason for Recall
- Possibility of stress related cracks occurring in our power elevating seat actuator models as the result of atypical or extreme usage of the wheelchair seating system.
- Trade Name
- A) Vacora Vacuum Biopsy System
B) Vacora Vacuum Biopsy System - Cannula - Recall Posting Date
- 2009-06-08
- Manufacturer
- Bard Peripheral Vascular, Inc.
- Recall Start Date
- 2009-04-14
- Recall Number
- 47925
- Hazard Classification
- Type II
- Model or Catalog #
- A) VC10118P
B) VC10118MR - Lot or Serial #
- A) HUSA1668, HUSC1533, HUSD1075, HUSI1063, HUSG0594
B) HUSH0816, HUSI0216, HUSC1588, HUSD2647 - Reason for Recall
- Some Vacora 10g plastic coaxial cannulas may leave a small metal filament in the breast.
- Trade Name
- A) Vitros 3600 Immunodiagnostic Software
B) Vitros 5600 Integrated System Software - Recall Posting Date
- 2009-06-22
- Manufacturer
- Ortho-Clinical Diagnostics Inc.
- Recall Start Date
- 2009-05-28
- Recall Number
- 48864
- Hazard Classification
- Type II
- Model or Catalog #
- A) 680 2865
B) 680 2863 - Lot or Serial #
- A) 36000116, 36000130
B) 56000193, 56000298, 56000124, 56000136, 56000336, 56000337 - Reason for Recall
- Complaint received of a biassed glucose result on a Vitros 5600 Integrated System. Investigation has found that under a very specific set of circumstances, when the display/report screen is configured by the operator, an erroneous result could also be generated by the Vitros 3600 Immunodiagnostic System.
- Trade Name
- A) Vitros Chemistry Slides - Creatine
B) Vitros Chemistry Slides - Enzymatic CO2
C) Vitros Chemistry Slides - CSF Protein
D) Vitros Chemistry Slides - Total Bilirubin - Recall Posting Date
- 2009-04-13
- Manufacturer
- Ortho-Clinical Diagnostics Inc.
- Recall Start Date
- 2009-03-31
- Recall Number
- 47712
- Hazard Classification
- Type III
- Model or Catalog #
- A) 680 2584
B) 8262396
C) 8208431
D) 8159931 - Lot or Serial #
- Reason for Recall
- The foil wrapper for specific lots of slide cartridges may have been damaged during the packaging process. Exposure of slides to uncontrolled environmental conditions could impact performance.
- Trade Name
- A) Wiseguide Guide Catheter Femoral
B) Wiseguide Guide Catheter Allright
C) Wiseguide Guide Catheter Voda
D) Wiseguide Guide Catheter Amplatz
E) Wiseguide Guide Catheter Bypass
F) Wiseguide Guide Catheter Multipurpose
G) Wiseguide Guide Catheter Radial
H) Wiseguide Guide Catheter Kimny - Recall Posting Date
- 2009-06-22
- Manufacturer
- Medi-Tech Boston Scientific Corporation
- Recall Start Date
- 2009-03-13
- Recall Number
- 47359
- Hazard Classification
- Type III
- Model or Catalog #
- A) 16320-02, 19500-02, 19500-29, 19815-92, H74919815520
B) 19815-501
C) 16320-72, 16320-78, 19500-71, 19500-72, 19500-73, 19500-74, 19500-77, 19500-78, 19815-71, 19815-72, 19815-73, 19815-74
D) 16320-17, 16320-18, 16320-20, 16320-21, 19500-20, 19500-21, 19500-22
E) 19815-446
F) 16320-141, 19500-39, 19815-41
G) 19815-554
H) 19815-583 - Lot or Serial #
- A) H74916320021, H74919500020, H74919500290, H74919815920
B) H749198155010
C) H74916320721, H74916320781, H74919500710, H74919500720, H74919500730, H74919500740, H74919500770, H74919500780, H74919815710, H74919815720, H74919815730, H74919815740
D) H74916320171, H74916320181, H74916320201, H74916320211, H74919500210, H74919500220,
E) H749198154460
F) H749163201411, H74919500390, H74919815410
G) H749198155540
H) H749198155830 - Reason for Recall
- Difficulties in connecting the product hubs with the Y-adaptors and toughy borst connectors. Product out of specs with thread outer diameters.
- Trade Name
- A) Zenith Renu AAA Converter
B) Zenith Renu AAA Main Body
C) Zenith AAA Main Body Bifurcated Stent - Recall Posting Date
- 2009-05-25
- Manufacturer
- Cook, Inc.
- Recall Start Date
- 2009-03-16
- Recall Number
- 47349
- Hazard Classification
- Type II
- Model or Catalog #
- A) N/A
B) N/A
C) N/A - Lot or Serial #
- A) All Lots
B) All Lots
C) All Lots - Reason for Recall
- In rare cases the trigger wire can become damaged and then compressed between the stent and the top cap, making it difficult to remove.
- Trade Name
- Access Systems Total BHCG Reagent Kit
- Recall Posting Date
- 2009-04-13
- Manufacturer
- Beckman Coulter Inc.
- Recall Start Date
- 2009-03-16
- Recall Number
- 47348
- Hazard Classification
- Type II
- Model or Catalog #
- 33500
- Lot or Serial #
- 824542, 825652
- Reason for Recall
- There is an increase in background relative light units (RLU) when comparing results between when a pack is first mixed/loaded and after it has settled on the instrument for 10 hours or more. This may produce a shift in results.
- Trade Name
- Accu-Chek Spirit Insulin Pump
- Recall Posting Date
- 2009-05-25
- Manufacturer
- Disetronic Medical Systems AG
- Recall Start Date
- 2009-04-17
- Recall Number
- 48163
- Hazard Classification
- Type II
- Model or Catalog #
- 04540492001, 04759702001, 04759729001
- Lot or Serial #
- SN02053575 to SN10006093
- Reason for Recall
- The insulin pump (numbers SN02053575 - SN10006093) may fail. This failure may present an intermittent or complete loss of function of the up and/or down buttons and in turn affect the desired pump operation.
- Trade Name
- Acist Angiographic System-Manifold Kit
- Recall Posting Date
- 2009-06-08
- Manufacturer
- Acist Medical Systems Inc.
- Recall Start Date
- 2009-05-13
- Recall Number
- 48480
- Hazard Classification
- Type II
- Model or Catalog #
- BT2000
- Lot or Serial #
- 3168H
- Reason for Recall
- The manufacturer has received field reports of a bulge and leaks on the side of the 2.5" high-pressure tubing of BT2000 kits during a procedure which can result in unsatisfactory performance of the product.
- Trade Name
- Acuson S2000
- Recall Posting Date
- 2009-05-11
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Recall Start Date
- 2009-04-14
- Recall Number
- 48076
- Hazard Classification
- Type III
- Model or Catalog #
- 10041461
- Lot or Serial #
- 200252, 200926, 200979, 200995
- Reason for Recall
- When performing a tee exam with the V5MS Transducer, CW (continuous wave) mode is not functional. A waveform signal cannot be detected. This event occurs on every attempt to acquire a CW signal.
- Trade Name
- Acuson S2000 VA10
- Recall Posting Date
- 2009-05-25
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Recall Start Date
- 2009-04-14
- Recall Number
- 48077
- Hazard Classification
- Type II
- Model or Catalog #
- 10041461
- Lot or Serial #
- 200334, 200288
- Reason for Recall
- A series of events could cause the last image to be stored with the next new patient performed, L Teslia Mass 2 measurement label appears in the report in English only, more than 4 measurements may print.
- Trade Name
- Acuson X300 PE Swiftlink
- Recall Posting Date
- 2009-05-11
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Recall Start Date
- 2009-04-07
- Recall Number
- 47911
- Hazard Classification
- Type III
- Model or Catalog #
- 10348531
- Lot or Serial #
- 313288, 313171, 313273
- Reason for Recall
- Swiftlink adapters manufactured prior to October 2008 can cause a failure that results in image quality when using Acunav catheter transducers that does not support intra-cardiac diagnosis or procedure guidance.
- Trade Name
- Advance Perfusion System 1
- Recall Posting Date
- 2009-06-08
- Manufacturer
- Terumo Cardiovascular Systems Corp.
- Recall Start Date
- 2009-01-29
- Recall Number
- 46444
- Hazard Classification
- Type II
- Model or Catalog #
- 802100
- Lot or Serial #
- 31, 39, 55, 93, 219, 220, 263, 279, 584
- Reason for Recall
- Poor or intermittent connections. A non functioning CCM could potentially cause the user to operate pumps using local pump controls.
- Trade Name
- Advia 70 Testpoint Haemotology High Con
- Recall Posting Date
- 2009-06-08
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Recall Start Date
- 2009-05-12
- Recall Number
- 48471
- Hazard Classification
- Type III
- Model or Catalog #
- B03-4585-54
- Lot or Serial #
- TP93037
- Reason for Recall
- Complaints that the Percent Eosinophils (EOS) is not recovering within the range specified for lot TP93037 of testpoint high control. The supplier confirmed a value assignment error for this lot.
- Trade Name
- Alumina Ceramic Femoral Head
- Recall Posting Date
- 2009-06-22
- Manufacturer
- Zimmer Inc.
- Recall Start Date
- 2009-06-01
- Recall Number
- 48988
- Hazard Classification
- Type II
- Model or Catalog #
- 00-6428-032-02
- Lot or Serial #
- 61007046
- Reason for Recall
- Some units in this lot may have the inner tyvek peel tab trapped within the outer seal. This configuration could result in delamination of the inner tyvek seal as the package is opened, complicating removal of the implant from the package while maintaining sterility.
- Trade Name
- Architect Reaction Vessel
- Recall Posting Date
- 2009-06-22
- Manufacturer
- Abbott Laboratories Diagnostic Division
- Recall Start Date
- 2009-05-19
- Recall Number
- 48605
- Hazard Classification
- Type II
- Model or Catalog #
- 7C15-01
- Lot or Serial #
- > 10 Numbers, Contact Manufactuer
- Reason for Recall
- Reaction vessels made from specific lots of resin had an increased likelihood of producing error code 1006 and error code 1007 and incorrect/elevated results.
- Trade Name
- Aria Radiation Oncology
- Recall Posting Date
- 2009-06-22
- Manufacturer
- Varian Medical Systems, Inc.
- Recall Start Date
- 2009-05-08
- Recall Number
- 49074
- Hazard Classification
- Type II
- Model or Catalog #
- 8.1.15, 8.5.11, 8.6.07, HIT
- Lot or Serial #
- > 10 Numbers, Contact Manufactuer
- Reason for Recall
- Software anomaly leads to a record save fail in the case that a partially treated fraction has zero dose accumulation. If the change to the plan had been to parameters other than dose per fraction, treatment to incorrect volume could result, potentially leading to serious injury.
- Trade Name
- ASC 2000 Ambulatory Surgical Table
- Recall Posting Date
- 2009-06-22
- Manufacturer
- Mediland Enterprise Corporation
- Recall Start Date
- 2009-04-17
- Recall Number
- 48613
- Hazard Classification
- Type III
- Model or Catalog #
- MTS110003
- Lot or Serial #
- 07160407V3.01, 043600401V200, 043600402V200, 041600323V200, 045100705V300, 061400907V3.00, 061406905V300
- Reason for Recall
- Repetitive rubbing of the hydraulic hoses against the interior of the stainless steel shroud may result in the rupture of the hydraulic hosing causing loss of control of the table surface.
- Trade Name
- Austin Moore Stems - Curved 43 mm
- Recall Posting Date
- 2009-05-25
- Manufacturer
- Howmedica Osteonics - Stryker Ireland
- Recall Start Date
- 2009-04-27
- Recall Number
- 48207
- Hazard Classification
- Type II
- Model or Catalog #
- 6939-0-430
- Lot or Serial #
- LOIINRA
- Reason for Recall
- A size 43mm Austin Moore endoprosthesis curved stem was found packaged as a size 45mm stem.
- Trade Name
- AW Volumeshare2 - Software Options
- Recall Posting Date
- 2009-06-08
- Manufacturer
- GE Healthcare
- Recall Start Date
- 2009-04-21
- Recall Number
- 45984
- Hazard Classification
- Type II
- Model or Catalog #
- B79011MA
- Lot or Serial #
- S/N'S 96090GE6, 96091GE4, 98606GE7, 98607GE5, 98608GE3
- Reason for Recall
- Under certain conditions, the series could be incorrectly labelled in image view, which could lead to under-treatment of a tumour.
- Trade Name
- Bard Max-Core Disposable Biopsy Instr.
- Recall Posting Date
- 2009-04-13
- Manufacturer
- Bard Peripheral Vascular, Inc.
- Recall Start Date
- 2009-03-09
- Recall Number
- 47251
- Hazard Classification
- Type II
- Model or Catalog #
- MC1810, MC1816, MC1820
- Lot or Serial #
- RESH0255, RESH0057, RESH0736, RESI0279, RESI0451
- Reason for Recall
- Incorrect label. Label indicates a length of sample notch of 1.9cm (19mm), where actual product is 1.8cm (18mm), a potential difference of 1mm in length.
- Trade Name
- BD Falcon 100X20 mm Tissue Culture
- Recall Posting Date
- 2009-06-22
- Manufacturer
- Becton, Dickinson And Company
- Recall Start Date
- 2009-02-17
- Recall Number
- 47220
- Hazard Classification
- Type III
- Model or Catalog #
- N/A
- Lot or Serial #
- > 10 Numbers, Contact Manufactuer
- Reason for Recall
- Dishes containing a small crack, which may result in the leakage of cell culture media during incubation. This crack is located on the bottom of the dish along the stacking ring.
- Trade Name
- Brilliance 6/10/16 Slice CT-SFRTWR Dent
- Recall Posting Date
- 2009-06-22
- Manufacturer
- Philips Medical Systems (Cleveland), Inc.
- Recall Start Date
- 2009-06-10
- Recall Number
- 49151
- Hazard Classification
- Type II
- Model or Catalog #
- 455011202691
- Lot or Serial #
- N/A
- Reason for Recall
- 1. When images are saved or filmed that contain the curved multi_planar reformation section (CMPRS) while using the dental application v4.0.0 to v4.0.1.9999 on the extended brilliance workspace, the right/left annotations will be reversed on views that were created with a short curve.
- Trade Name
- Byrd Screw 2.0x6mm Self Drilling
- Recall Posting Date
- 2009-04-13
- Manufacturer
- Walter Lorenz Surgical, Inc. Also Trading As: Biomet Microfixation
- Recall Start Date
- 2009-02-20
- Recall Number
- 46721
- Hazard Classification
- Type II
- Model or Catalog #
- 01-0267
- Lot or Serial #
- 91807107
- Reason for Recall
- The 01-0267 Byrd screw may break when being used.
- Trade Name
- C2A Ringloc Acetabular System - 28 mm
- Recall Posting Date
- 2009-04-13
- Manufacturer
- Biomet Orthopedics, Inc.
- Recall Start Date
- 2009-03-16
- Recall Number
- 47389
- Hazard Classification
- Type II
- Model or Catalog #
- 12-115112(RD115112)
- Lot or Serial #
- All Lots
- Reason for Recall
- Possibility of ceramic heads fracturing with +5mm offset.
- Trade Name
- CADD-SOLIS Rechargeable Battery Pack
- Recall Posting Date
- 2009-05-25
- Manufacturer
- Smiths Medical MD Inc.
- Recall Start Date
- 2009-04-30
- Recall Number
- 48233
- Hazard Classification
- Type III
- Model or Catalog #
- 21-2160-51
- Lot or Serial #
- >10 Numbers, Contact Manufacturer
- Reason for Recall
- Reports received that when the battery pack is first installed in pump, the pump will not power up or an alarm sounds and an error message displays indicating that battery pack is unusable and pump will not run.
- Trade Name
- Carescape V100
- Recall Posting Date
- 2009-06-22
- Manufacturer
- GE Medical Systems Information Technologies
- Recall Start Date
- 2009-02-09
- Recall Number
- 46236
- Hazard Classification
- Type II
- Model or Catalog #
- V100-QBAA-CXAA-XX
- Lot or Serial #
- > 10 Numbers, Contact Manufactuer
- Reason for Recall
- The alarm and pulse volume indicators are inverted on the label of french language units.
- Trade Name
- Chemiluminescent Substrate
- Recall Posting Date
- 2009-06-22
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Recall Start Date
- 2009-05-06
- Recall Number
- 48608
- Hazard Classification
- Type III
- Model or Catalog #
- L2SUBX
- Lot or Serial #
- 253, 254
- Reason for Recall
- Complaints received regarding substrate l2subx lots 253 and 254, which may affect the performance of the Immulite 2000 and Immulite 2500 assays. These substrate lots may introduce a shift in both quality control and patient results.
- Trade Name
- CIC Pro Clinical Information Center
- Recall Posting Date
- 2009-06-22
- Manufacturer
- GE Healthcare
- Recall Start Date
- 2009-02-19
- Recall Number
- 46853
- Hazard Classification
- Type II
- Model or Catalog #
- CIC-XXXX-XXXXX-XXXXX*
- Lot or Serial #
- S/N'S SDY09020430GA & SDY09030443GA
- Reason for Recall
- Circuit board supplied by 3rd party for MP 100 hardware platform for CIC Pro version 5.1 software may fail and result in potential loss of monitoring and inability to power up after powering down of CIC Pro.
- Trade Name
- Compax 40E Table
- Recall Posting Date
- 2009-06-22
- Manufacturer
- GE Healthcare
- Recall Start Date
- 2009-02-18
- Recall Number
- 45258
- Hazard Classification
- Type II
- Model or Catalog #
- N/A
- Lot or Serial #
- > 10 Numbers, Contact Manufactuer
- Reason for Recall
- Table locks may not actuate, causing tabletop to unexpectedly float in either of the following axes: 1) lateral axes, 2) bidirectional (longitudinal and lateral) axes, which could injure patient or user.
- Trade Name
- Coronary Scissors 7"
- Recall Posting Date
- 2009-04-13
- Manufacturer
- Teleflex Medical
- Recall Start Date
- 2009-03-09
- Recall Number
- 47208
- Hazard Classification
- Type II
- Model or Catalog #
- 352164, 352165, 352166, 352167, 352168
- Lot or Serial #
- Date Codes RR8, SS8, TT8, UU8, VV8, WW8, XX8, MM9.
- Reason for Recall
- Manufacturing defect consisting of a rough square finish to the scissor tips, rather than a smooth rounded point, may cause damage to the inner wall of the blood vessel, rendering it unsuitable for bypass graft.
- Trade Name
- Custom-Pak Opthalmic Surgery Pak
- Recall Posting Date
- 2009-06-08
- Manufacturer
- Alcon Laboratories Inc.
- Recall Start Date
- 2009-05-01
- Recall Number
- 48472
- Hazard Classification
- Type II
- Model or Catalog #
- 13305-01
- Lot or Serial #
- 894213H
- Reason for Recall
- Identification of oxidization on some of the 25GA Trocar Blades packaged in the 25GA Total Plus paks which are part of the Alcon custom-pak procedure pack.
- Trade Name
- Cypher Select + Sirolimus-Eluting Stent
- Recall Posting Date
- 2009-06-08
- Manufacturer
- Cordis Europa N.V.
- Recall Start Date
- 2009-05-08
- Recall Number
- 48561
- Hazard Classification
- Type III
- Model or Catalog #
- CRB08225, CRB08250, CRB08275, CRB08300, CRB08350, CRB13225, CRB13250, CRB13275, CRB13300, CRB13350, CRB18225, CRB18250, CRB18275, CRB18300, CRB18350, CRB23225, CRB23250, CRB23275, CRB23300, CRB23350, CRB28225, CRB28250, CRB28275, CRB28300, CRB28350, CRB33225, CRB33250, CRB33275, CRB33300, CRB33350
- Lot or Serial #
- >100 Lots, Contact Manufacturer
- Reason for Recall
- In response to an increased number of complaints of cracks in the balloon inflation port hub of this coronary stent, a field safety notice has been issued to remind users to follow inspection and preparation steps.
- Trade Name
- Definition AS
- Recall Posting Date
- 2009-06-08
- Manufacturer
- Siemens AG
- Recall Start Date
- 2009-02-25
- Recall Number
- 48470
- Hazard Classification
- Type III
- Model or Catalog #
- 8098027
- Lot or Serial #
- 64238, 64032, 64049, 64052, 64069, 64137, 64141, 64233, 64306,
64316, 64362 - Reason for Recall
- This update instruction provides improved fixation of the telescope support.
- Trade Name
- Delfia Xpress PAPP-A
- Recall Posting Date
- 2009-04-27
- Manufacturer
- Wallac OY
- Recall Start Date
- 2009-03-26
- Recall Number
- 47713
- Hazard Classification
- Type III
- Model or Catalog #
- 6003-0020
- Lot or Serial #
- 510998, 515079, 511590
- Reason for Recall
- Some tracer bottles in the Delfia Xpress PAPP-A kit have bar codes which cannot be read in the Delfia Xpress instrument.
- Trade Name
- Derma Prene Ultra Surgical Glove
- Recall Posting Date
- 2009-05-25
- Manufacturer
- Ansell Healthcare Products LLC
- Recall Start Date
- 2009-05-04
- Recall Number
- 48229
- Hazard Classification
- Type II
- Model or Catalog #
- 851365, 851470
- Lot or Serial #
- 0810006605, 0810006705
- Reason for Recall
- Some gloves may be discoloured as a result of film degradation. This degradation results in film strength properties below the ASTM performance standard for surgeon's gloves.
- Trade Name
- Disposable Endoscopic Surgery Blades
- Recall Posting Date
- 2009-06-22
- Manufacturer
- Smith & Nephew, Inc., Endoscopy Division
- Recall Start Date
- 2009-05-08
- Recall Number
- 48408
- Hazard Classification
- Type II
- Model or Catalog #
- 7206010, 7206011, 7210499
- Lot or Serial #
- 20148707, 20148714, 20153849, 20153865, 20154971
- Reason for Recall
- There is the potential for a compromised sterile barrier in the tyvek lid of the primary packaging.
- Trade Name
- Dyonics 25 Tube Set Kits
- Recall Posting Date
- 2009-06-22
- Manufacturer
- Smith & Nephew, Inc., Endoscopy Division
- Recall Start Date
- 2009-05-29
- Recall Number
- 48968
- Hazard Classification
- Type II
- Model or Catalog #
- 7211005, 7211006
- Lot or Serial #
- > 10 Numbers, Contact Manufactuer
- Reason for Recall
- The material thickness of the trays used for packaging the tube sets may not be sufficient to maintain the sterile barrier.
- Trade Name
- Eccentric Bushes
- Recall Posting Date
- 2009-05-11
- Manufacturer
- Kaltenbach & Voight GMBH
- Recall Start Date
- 2009-01-18
- Recall Number
- 47039
- Hazard Classification
- Type III
- Model or Catalog #
- 0.535.4692
- Lot or Serial #
- N/A
- Reason for Recall
- A nonconformance with the Eccentric Bushes can result in a rough surface that will result in altered revolutions per minute(RPM) and the lifetime of the device.
- Trade Name
- Erytype S RH Donor Plates
- Recall Posting Date
- 2009-06-22
- Manufacturer
- Biotest Medical Diagnostics GMBH
- Recall Start Date
- 2009-04-03
- Recall Number
- 49138
- Hazard Classification
- Type III
- Model or Catalog #
- 806190100
- Lot or Serial #
- 7839010, 7910010
- Reason for Recall
- One lot of Erytype S RH Donor Plates contains an error in the labelling on the foil packet. The product is correctly identified, however the product description immediately below is incorrectly stated. The outer box information is correct as well as the barcode information on the plate frames and microplate strips.
- Trade Name
- Factor II (Prothrombin) G20210A Kit
- Recall Posting Date
- 2009-04-27
- Manufacturer
- Roche Molecular Systems, Inc
- Recall Start Date
- 2009-04-06
- Recall Number
- 47434
- Hazard Classification
- Type III
- Model or Catalog #
- 3610195001
- Lot or Serial #
- All Lots
- Reason for Recall
- The macro component intended to be used with the Factor II G20210A Kit for LightCycler 2.0 instrument may erroneously identify the C20209T mutation as a wild-type genotype instead of an unknown genotype.
- Trade Name
- Flow-Set Fluorospheres
- Recall Posting Date
- 2009-04-13
- Manufacturer
- Beckman Coulter Inc.
- Recall Start Date
- 2009-03-16
- Recall Number
- 47347
- Hazard Classification
- Type II
- Model or Catalog #
- 6607007
- Lot or Serial #
- 7524003F, 7524004F, 7524005F, 7524006F
- Reason for Recall
- Current flow set labelling does not provide new target settings for tetra applications.
- Trade Name
- Focal Software CD
- Recall Posting Date
- 2009-05-11
- Manufacturer
- Computerized Medical Systems
- Recall Start Date
- 2009-04-09
- Recall Number
- 48015
- Hazard Classification
- Type II
- Model or Catalog #
- Focal SIM
- Lot or Serial #
- N/A
- Reason for Recall
- Setup reference point incorrectly defined for prone patients when manual shifts are used.
- Trade Name
- Folate III Reagent Kit
- Recall Posting Date
- 2009-06-08
- Manufacturer
- Roche Diagnostics GMBH
- Recall Start Date
- 2009-05-08
- Recall Number
- 48241
- Hazard Classification
- Type III
- Model or Catalog #
- 4476433190
- Lot or Serial #
- 15068201, 15127201
- Reason for Recall
- Certain lots of the Folate III Reagent Kit may induce an elevated recovery of folate in li-heparin plasma.
- Trade Name
- Galileo Echo Blood Bank Analyzer
- Recall Posting Date
- 2009-06-08
- Manufacturer
- Immucor Inc.
- Recall Start Date
- 2009-04-27
- Recall Number
- 48195
- Hazard Classification
- Type II
- Model or Catalog #
- 87000
- Lot or Serial #
- N/A
- Reason for Recall
- Improvements of Echo software since the 1.1.2.28.1, to address the recalls previously initiated: duplicate alphabetical sample barcodes, information for instruments interfaced to laboratory information system.
- Trade Name
- Gallileo Echo Blood Bank Analyzer
- Recall Posting Date
- 2009-05-11
- Manufacturer
- Immucor Inc.
- Recall Start Date
- 2009-04-02
- Recall Number
- 47888
- Hazard Classification
- Type II
- Model or Catalog #
- 87000
- Lot or Serial #
- N/A
- Reason for Recall
- Incorrect patient demographic information could be associated with a sample ID. This only occurs when manually ordering an assay using the run test wizard on instrument with bi-directional interface capability.
- Trade Name
- GT Series X
- Recall Posting Date
- 2009-04-13
- Manufacturer
- Dentsply Tulsa Dental Specialties
Trading As Dentsply Endodontics - Recall Start Date
- 2009-03-30
- Recall Number
- 47759
- Hazard Classification
- Type III
- Model or Catalog #
- SXR0602021, SXR0602025
- Lot or Serial #
- 073008100, 062608322
- Reason for Recall
- 25mm length files were mislabeled as 21mm (SXR0602021), and 21mm length files were mislabeled as 25 mm (SXR0602025).
- Trade Name
- Heartstart MRX Defibrillator / Monitor
- Recall Posting Date
- 2009-04-27
- Manufacturer
- Philips Medical Systems
- Recall Start Date
- 2009-04-09
- Recall Number
- 47916
- Hazard Classification
- Type II
- Model or Catalog #
- M3535A, M3536A
- Lot or Serial #
- S/N US00210406 TO US00333123
- Reason for Recall
- The therapy switch has a small potential to fail. Most likely failure mode is spontaneous turn-on which could deplete the battery, rendering the device unstable until power is restored.
- Trade Name
- Heartstart XL
- Recall Posting Date
- 2009-04-27
- Manufacturer
- Philips Medical Systems
- Recall Start Date
- 2009-04-09
- Recall Number
- 47915
- Hazard Classification
- Type II
- Model or Catalog #
- M4735A
- Lot or Serial #
- S/N US00442485 to US00469873
- Reason for Recall
- The rotary energy switch may fail and prevent the user from turning the device on, rendering it unusable for monitoring and defibrillation therapy. The failure may also occur by spontaneously powering on.
- Trade Name
- Hill ROM Totalcare Bed
- Recall Posting Date
- 2009-04-13
- Manufacturer
- Hill-ROM Company, Inc.
- Recall Start Date
- 2009-03-09
- Recall Number
- 47219
- Hazard Classification
- Type II
- Model or Catalog #
- N/A
- Lot or Serial #
- J329AMXXX to J340AM1369
- Reason for Recall
- E-ring may not fully be seated on the siderail bracket. It could cause the e-ring to be missing and could result in an inability to latch the siderail.
- Trade Name
- Hinged Knee Brace
- Recall Posting Date
- 2009-06-22
- Manufacturer
- Trainer's Choice
- Recall Start Date
- 2009-01-07
- Recall Number
- 48389
- Hazard Classification
- Type III
- Model or Catalog #
- 101
- Lot or Serial #
- 8-31313-00003-2, 8-31313-00004-9, 8-31313-00002-5
- Reason for Recall
- Evidence of mold was found on the leather pieces on the outside of the braces. Product integrity and effectiveness was not affected.
- Trade Name
- Holter
- Recall Posting Date
- 2009-04-27
- Manufacturer
- Philips Medical Systems
- Recall Start Date
- 2009-03-30
- Recall Number
- 47704
- Hazard Classification
- Type II
- Model or Catalog #
- 1810, 2010+
- Lot or Serial #
- N/A
- Reason for Recall
- Holter software version 2.9 and 2.9.1 may contain problems which could affect its performance.
- Trade Name
- Human STFR Quantikine IVD Kit
- Recall Posting Date
- 2009-06-08
- Manufacturer
- R & D Systems, Inc.
- Recall Start Date
- 2009-03-03
- Recall Number
- 48601
- Hazard Classification
- Type II
- Model or Catalog #
- N/A
- Lot or Serial #
- 259416, 261514, 262759
- Reason for Recall
- During manufacturing, it was found the standard used to calibrate the assay, may have evaporated in some vials. If evaporation occurs this will cause the standards to read erroneously.
- Trade Name
- Infinity Glucose Hexokinase Reagent
- Recall Posting Date
- 2009-05-11
- Manufacturer
- Fisher Diagnostics, A Division Of Fisher Scientific CO, LLC
- Recall Start Date
- 2009-04-09
- Recall Number
- 47989
- Hazard Classification
- Type II
- Model or Catalog #
- TR15498
- Lot or Serial #
- V28015
- Reason for Recall
- Failure of product to meet the stated performance specifications for shelf life, resulting in linearity of less than the stated specifications.
- Trade Name
- Insight Rev H Software-GI Motility System
- Recall Posting Date
- 2009-05-25
- Manufacturer
- Sandhill Scientific Inc.
- Recall Start Date
- 2009-02-23
- Recall Number
- 47672
- Hazard Classification
- Type III
- Model or Catalog #
- S98-1925-2H
- Lot or Serial #
- All Lots
- Reason for Recall
- In HRIM or EFT, patients with non-transmitted esophageal contractions that have been acquired with this software, the report may incorrectly report the esophageal contraction results.
- Trade Name
- In-Situ Bender/Cutter
- Recall Posting Date
- 2009-05-11
- Manufacturer
- Synthes (Canada) Ltd.
- Recall Start Date
- 2009-04-09
- Recall Number
- 47833
- Hazard Classification
- Type II
- Model or Catalog #
- 530.521S, 530.522S
- Lot or Serial #
- All Lots
- Reason for Recall
- During examination of shelf life samples as part of real time shelf life validation, the company became aware of and confirmed a breach of the sterile pouch barrier.
- Trade Name
- Instrument Manager
- Recall Posting Date
- 2009-06-22
- Manufacturer
- Data Innovations
- Recall Start Date
- 2009-05-11
- Recall Number
- 48997
- Hazard Classification
- Type II
- Model or Catalog #
- IM-B02V8.06, IM-B02V8.07, IM-B02V8.08,
IM-B02V8.09 - Lot or Serial #
- N/A
- Reason for Recall
- The previous results retrieved from the specimen management database, which may be used by rules, may not be the most recent previous version.
- Trade Name
- Insufflation Tubing With Filter
- Recall Posting Date
- 2009-06-08
- Manufacturer
- Medovations Inc.
- Recall Start Date
- 2009-05-14
- Recall Number
- 48488
- Hazard Classification
- Type II
- Model or Catalog #
- SU1101
- Lot or Serial #
- 209296
- Reason for Recall
- The device, model SU1101, is not licensed for sale in Canada. It is however the same product in specifications and materials as JA-1101, which is licensed for sale in Canada.
- Trade Name
- Integra CEM
- Recall Posting Date
- 2009-05-11
- Manufacturer
- Premier Dental Products Company
DBA Premier Medical - Recall Start Date
- 2009-03-25
- Recall Number
- 48059
- Hazard Classification
- Type II
- Model or Catalog #
- 3001410
- Lot or Serial #
- All Lots
- Reason for Recall
- Sale or distribution of the Integra CEM (item #3001410) is in violation of the medical devices regulations. The Integra CEM is not licensed as required per section 26 of the medical devices regulations.
- Trade Name
- Intellivue MP70 Patient Monitor System
- Recall Posting Date
- 2009-06-22
- Manufacturer
- Philips Medizin Systeme Boeblingen GMBH
- Recall Start Date
- 2009-05-22
- Recall Number
- 48839
- Hazard Classification
- Type II
- Model or Catalog #
- M8007A
- Lot or Serial #
- N/A
- Reason for Recall
- If scheduled orders are documented and edited prior to the orders' original schedule time,
Carevue Chart Release C.0 (running on the DC7100 computers of the Intellivue MP700 patient monitor
system) can create a second instance of the same order marked as pending, if the following conditions
occur:
1. An order or intervention is entered as a scheduled administration and
2. A clinician charts the pending order earlier than scheduled and
3. A user/clinician changes, edits or acknowledges the
- Trade Name
- i-STAT 1 Analyzer System-Instrument
- Recall Posting Date
- 2009-05-25
- Manufacturer
- Abbott Point Of Care Inc.
- Recall Start Date
- 2009-04-27
- Recall Number
- 48245
- Hazard Classification
- Type II
- Model or Catalog #
- 06F16-10
- Lot or Serial #
- >100 Numbers, Contact Manufacturer
- Reason for Recall
- The rechargeable battery pack can overheat with or without the presence of smoke causing the Martel printer to overheat in the i-STAT 1 analyzer system.
- Trade Name
- Kinedx 4.2 SPF Reporting Workstation
- Recall Posting Date
- 2009-05-25
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Recall Start Date
- 2009-02-05
- Recall Number
- 46559
- Hazard Classification
- Type III
- Model or Catalog #
- N/A
- Lot or Serial #
- 92172-1
- Reason for Recall
- Under certain circumstances, when editing text in a report, it may result in additional phrases not populating as expected.
- Trade Name
- Leckey Four-Point Pelvic Harness
- Recall Posting Date
- 2009-05-11
- Manufacturer
- Leckey (James Leckey Design)
- Recall Start Date
- 2009-04-15
- Recall Number
- 47922
- Hazard Classification
- Type II
- Model or Catalog #
- 122-719
- Lot or Serial #
- LEC/019910-LEC/043681
- Reason for Recall
- The central plastic buckle degrades and can fail in use. The belts are used in the James Leckey seating systems: mobile advance seat, contoured advance seat, squiggles early sitting system, squiggles saddle seat.
- Trade Name
- Lifepak 12 Defibrillator / Monitor
- Recall Posting Date
- 2009-05-11
- Manufacturer
- Physio-Control, Inc.
- Recall Start Date
- 2009-04-09
- Recall Number
- 48000
- Hazard Classification
- Type II
- Model or Catalog #
- LP 12
- Lot or Serial #
- >10 Numbers, Contact Manufacturer
- Reason for Recall
- Affected defibrillator /monitors may have a solder defect on the H bridge component that could prevent the device from providing a defibrillation shock.
- Trade Name
- Lifepak 9/9P Internal Paddles & Handles
- Recall Posting Date
- 2009-06-08
- Manufacturer
- Physio-Control, Inc.
- Recall Start Date
- 2009-02-17
- Recall Number
- 48161
- Hazard Classification
- Type II
- Model or Catalog #
- 11130-0000XX, 11131-0000XX, 800441-XX, 802154-XX
- Lot or Serial #
- > 10, Contact Manufacturer
- Reason for Recall
- Sterilization efficacy for the current labelled methods cannot be confirmed. These Lifepak 9/9P internal defibrillation handles without discharge control & custom-mated paddles, were discontinued in August 2008.
- Trade Name
- List No. 620 PCS2 Harness Set
- Recall Posting Date
- 2009-04-27
- Manufacturer
- Haemonetics Corporation
- Recall Start Date
- 2009-04-13
- Recall Number
- 47918
- Hazard Classification
- Type III
- Model or Catalog #
- 00620-00
- Lot or Serial #
- LN 081219511 and 081219512, LN 081222510 and 081222511,
LN 081223510 and 081223511, LN 081224510 to 081224512 - Reason for Recall
- This recall is the result of reports of leaks at the blood filter of the Haemonetics lN620 PCS2 Plasma Harness Set.
- Trade Name
- Medical Flat Panel Power Supply
- Recall Posting Date
- 2009-04-13
- Manufacturer
- Spacelabs Medical, Inc.
- Recall Start Date
- 2009-03-25
- Recall Number
- 47582
- Hazard Classification
- Type II
- Model or Catalog #
- 010-1619-00, 010-1655-00
- Lot or Serial #
- 0647, 0703, 0706, 0707, 0709, 0712, 0724, 0727, 0728, 0732
- Reason for Recall
- The external power supply used with certain models of the Spacelabs Medical 19" flat panel displays may fail prematurely, causing the display to go blank. Audio alarms continue to function normally.
- Trade Name
- Medline Penrose Drain
- Recall Posting Date
- 2009-05-25
- Manufacturer
- Medline Industries Inc.
- Recall Start Date
- 2009-04-21
- Recall Number
- 48072
- Hazard Classification
- Type II
- Model or Catalog #
- DYND50420, DYND50421, DYND50422, DYND50423, DYND50424, DYND50425, DYND50426
- Lot or Serial #
- 05AA0001-09CA9999
- Reason for Recall
- A drain placed by a surgeon and an x-ray ordered, the drain did not show up on x-ray although the packaging states the product is x-ray opaque. Two lots of product are affected in this issue.
- Trade Name
- Muse Cardiology Information System
- Recall Posting Date
- 2009-06-22
- Manufacturer
- GE Healthcare
- Recall Start Date
- 2009-03-04
- Recall Number
- 46833
- Hazard Classification
- Type II
- Model or Catalog #
- MUSESW7-XXXXXXXX
- Lot or Serial #
- > 10 Numbers, Contact Manufactuer
- Reason for Recall
- Stored and printed records may contain incorrect information when records containing default patient identifiers (PID) are confirmed as valid PID's in Muse Cardiology Information Systems versions 7.0, 7.01, 7.0.2, 7.1 & 7.1.1
- Trade Name
- Neogram Amino Acids Mass Spec Kit
- Recall Posting Date
- 2009-04-27
- Manufacturer
- Wallac OY
- Recall Start Date
- 2009-04-01
- Recall Number
- 47714
- Hazard Classification
- Type II
- Model or Catalog #
- 3026-0010, 3026-0030
- Lot or Serial #
- Contact Manufacturer
- Reason for Recall
- The truncated V-Bottomed Microplates delivered as a package of 10 plates may have occasional contamination which results in an apparent elevated C4 concentration in an affected well.
- Trade Name
- Nexcare Opticlude Orthoptic Eye Patch
- Recall Posting Date
- 2009-05-25
- Manufacturer
- 3M Canada Company
- Recall Start Date
- 2009-05-05
- Recall Number
- 48185
- Hazard Classification
- Type III
- Model or Catalog #
- 1539
- Lot or Serial #
- 900605, 902007, 902106
- Reason for Recall
- The primary boxes from these affected lots may not have the application instructions and caution statements printed on the inside flaps of the primary box, as otherwise indicated.
- Trade Name
- Norwex Silvercare Toothbrush
- Recall Posting Date
- 2009-04-13
- Manufacturer
- Norwex Enviro Products Inc.
- Recall Start Date
- 2009-03-17
- Recall Number
- 47238
- Hazard Classification
- Type II
- Model or Catalog #
- 22963
- Lot or Serial #
- N/A
- Reason for Recall
- Toothbrush head may pose a choking or swallowing hazard to children under three years of age or to individuals that would normally require supervision or assistance brushing their teeth.
- Trade Name
- Orthos CM Bracket
- Recall Posting Date
- 2009-05-25
- Manufacturer
- Ormco Corporation
- Recall Start Date
- 2009-02-13
- Recall Number
- 46601
- Hazard Classification
- Type III
- Model or Catalog #
- 454-0210, 454-1210
- Lot or Serial #
- 08H599H, 08H358H, 08J174J, 08J175J
- Reason for Recall
- Orthos CM Brackets are incorrectly labelled +9 degrees, but they have a torque of -9. Attachment will result in significant delay in treatment.
- Trade Name
- Paradigm Silhouette Infusion Sets
- Recall Posting Date
- 2009-04-13
- Manufacturer
- Unomedical A/S
- Recall Start Date
- 2009-04-01
- Recall Number
- 47734
- Hazard Classification
- Type II
- Model or Catalog #
- MMT-377600, MMT-378600, MMT-381600, MMT-382600
- Lot or Serial #
- 617095, 616520, 616521, 617090, 617094, 616522, 617089, 617093, 616523
- Reason for Recall
- A typographical error in the fixed prime volume listed in instructions for use. IFU tells users to fill empty space in the cannula with a fixed prime volume of 0.3 units of U-100 insulin, instead of 0.7 units.
- Trade Name
- Percutaneous Combination Stent
- Recall Posting Date
- 2009-04-13
- Manufacturer
- Boston Scientific Corporation
- Recall Start Date
- 2009-03-23
- Recall Number
- 47581
- Hazard Classification
- Type II
- Model or Catalog #
- 410-111, 410-112, 410-126, 410-202,
410-203, 410-204, 410-205, 410-206, 410-207, 410-304, 410-305 - Lot or Serial #
- > 100 Numbers, Contact Manufacturer
- Reason for Recall
- During the attempted removal of the device, sutures were separated from the catheter and remained in the patient. In one instance surgical intervention was opted to remove a suture.
- Trade Name
- PFC Sigma CR Non-Porous Left Femoral
- Recall Posting Date
- 2009-06-22
- Manufacturer
- Depuy Orthpaedics, Inc.
- Recall Start Date
- 2009-05-29
- Recall Number
- 48935
- Hazard Classification
- Type II
- Model or Catalog #
- 960005
- Lot or Serial #
- 2843263, 2869123, 2845534, 2845530, 2844799, 2952392, 2852394, 2842528, 2844381, 2843270, 2843268
- Reason for Recall
- A small number of PFC Sigma Cruciate Retaining Non-Porous size 5 left femoral cemented components within the affected lots have been identified as having a microscopic crack on the lateral side of the condyle in the posterior chamfer region. Microscopic cracks have the potential to affect the performance of the implant.
- Trade Name
- Philips Bougies
- Recall Posting Date
- 2009-04-27
- Manufacturer
- Coloplast A/S
- Recall Start Date
- 2009-01-23
- Recall Number
- 46373
- Hazard Classification
- Type II
- Model or Catalog #
- AG55XX
- Lot or Serial #
- All Manufactured Between 2003-2008
- Reason for Recall
- Product recall due to the possibility that the device tip could break during use.
- Trade Name
- Pneumo Sure XL High Flow Insufflator
- Recall Posting Date
- 2009-05-25
- Manufacturer
- Stryker Endoscopy
- Recall Start Date
- 2009-01-08
- Recall Number
- 45983
- Hazard Classification
- Type II
- Model or Catalog #
- 620-040-600, 620-040-610
- Lot or Serial #
- 0804CE394 to 0810CE295
- Reason for Recall
- Insufflators are powering off during surgery or not powering up completely.
- Trade Name
- Posey Buckle
- Recall Posting Date
- 2009-06-22
- Manufacturer
- J T Posey Co.
- Recall Start Date
- 2009-05-29
- Recall Number
- 48899
- Hazard Classification
- Type III
- Model or Catalog #
- N/A
- Lot or Serial #
- 235018, 235036, S27947, S27957
- Reason for Recall
- Product made with incorrect buckle, potential for failure.
- Trade Name
- Preciset TDM I / Preciset TDM II
- Recall Posting Date
- 2009-06-08
- Manufacturer
- Roche Diagnostics GMBH
- Recall Start Date
- 2009-05-12
- Recall Number
- 48228
- Hazard Classification
- Type III
- Model or Catalog #
- 03375781190, 03375790190
- Lot or Serial #
- 15617400 & 15612200, 15612300
- Reason for Recall
- Bottle caps are being too difficult to remove.
- Trade Name
- Prelude Short Sheath Introducer
- Recall Posting Date
- 2009-06-22
- Manufacturer
- Merit Medical Systems Inc.
- Recall Start Date
- 2009-04-20
- Recall Number
- 48882
- Hazard Classification
- Type II
- Model or Catalog #
- PSS-5F-4-018MT, PSS-5F-4-038MT, PSS-5F-4MT, PSS-6F-4-018MT, PSS-6F-4MT, PSS-7F-4MT, PSS-8F-4MT
- Lot or Serial #
- N/A
- Reason for Recall
- The sidearm tubing may detach from the sheath during use. If this failure occurs, it may result in excessive patient blood loss and/or risk of blood-borne pathogen exposure to those in the surrounding area.
- Trade Name
- Proultra Surgical Endo Tip
- Recall Posting Date
- 2009-05-11
- Manufacturer
- Dentsply Tulsa Dental Specialties
Trading As Dentsply Endodontics - Recall Start Date
- 2009-04-06
- Recall Number
- 48008
- Hazard Classification
- Type III
- Model or Catalog #
- PUSURG1
- Lot or Serial #
- 121808304
- Reason for Recall
- Prototype tips were mistakenly distributed to customers.
- Trade Name
- PSM with Validation Module
- Recall Posting Date
- 2009-05-25
- Manufacturer
- Roche Diagnostics Ltd
- Recall Start Date
- 2009-04-30
- Recall Number
- 47890
- Hazard Classification
- Type II
- Model or Catalog #
- 03009696001, 03265439001
- Lot or Serial #
- >10 Numbers, Contact Manufacturer
- Reason for Recall
- Potential situation where the test validation ranges configured in the process systems managers (PSM) can incorrectly release a patient result where there are multiple reference ranges defined.
- Trade Name
- Quantikine IVD Human B2-Microglobulin
- Recall Posting Date
- 2009-06-08
- Manufacturer
- R & D Systems, Inc.
- Recall Start Date
- 2009-03-04
- Recall Number
- 48674
- Hazard Classification
- Type II
- Model or Catalog #
- N/A
- Lot or Serial #
- 260980
- Reason for Recall
- During manufacturing, it was found the standard used to calibrate the assay, may have evaporated in some vials. If evaporation occurs this will cause the standards to read erroneously.
- Trade Name
- Quickie LXI Manual Wheelchair
- Recall Posting Date
- 2009-05-11
- Manufacturer
- Sunrise Mobility Products Division
- Recall Start Date
- 2009-02-02
- Recall Number
- 47380
- Hazard Classification
- Type II
- Model or Catalog #
- LXI
- Lot or Serial #
- LXI-034741, LXI-034609, LXI-034740, LXI-034500
- Reason for Recall
- Stabilizer bar was inadvertently omitted from the configuration due to a system error. Stabilizer bar adds rigidity to the back to reduce head movement should the chair be involved in a vehicular collision.
- Trade Name
- Ready Kit
- Recall Posting Date
- 2009-06-08
- Manufacturer
- Cardiac Science Corporation
- Recall Start Date
- 2009-02-10
- Recall Number
- 48618
- Hazard Classification
- Type III
- Model or Catalog #
- N/A
- Lot or Serial #
- N/A
- Reason for Recall
- Ready kits, part# 5550-003, contain gloves and antiseptic wipes that are not licensed in accordance with the medical devices regulations.
- Trade Name
- Restoration Modular Cone Bodies
- Recall Posting Date
- 2009-04-13
- Manufacturer
- Howmedica Osteonics - Stryker Ireland
- Recall Start Date
- 2009-03-27
- Recall Number
- 47576
- Hazard Classification
- Type II
- Model or Catalog #
- 6276-1-121, 6276-1-125, 6276-1-219, 6276-1-325
- Lot or Serial #
- 22125701, 21834602, 21883201, 21883401
- Reason for Recall
- Packaging test logs indicate burst test results fell below validation parameters. There may be deterioration of short or long term packaging integrity (inner or outer) with potential loss of sterility.
- Trade Name
- Roche/Hitachi Acetaminophen Assay
- Recall Posting Date
- 2009-05-25
- Manufacturer
- Roche Diagnostics GMBH
- Recall Start Date
- 2009-05-01
- Recall Number
- 48042
- Hazard Classification
- Type III
- Model or Catalog #
- 3255379190
- Lot or Serial #
- All Lot Numbers
- Reason for Recall
- The claim for significant bilirubin interference decreases from 28 mg/dl (478.8 µmol/l) to 20 mg/dl (342 µmol/l) icterus index for the Roche/Hitachi acetaminophen assay.
- Trade Name
- Servo 300
- Recall Posting Date
- 2009-04-13
- Manufacturer
- Maquet Critical Care AB
- Recall Start Date
- 2009-03-27
- Recall Number
- 47623
- Hazard Classification
- Type II
- Model or Catalog #
- 6079300, 6079391, 6079433, 6150614, 6424704, 6424779
- Lot or Serial #
- > 10 Numbers, Contact Manufacturer
- Reason for Recall
- Printed circuit boards have stopped working, results in expiratory valve staying in the open position, sometimes preceded by a short valve closure. Remote hazard of serious adverse health consequences.
- Trade Name
- Sigma Pacemaker System
- Recall Posting Date
- 2009-06-08
- Manufacturer
- Medtronic Inc.
- Recall Start Date
- 2009-05-18
- Recall Number
- 48702
- Hazard Classification
- Type I
- Model or Catalog #
- SD203, SD303, SDR203, SDR303, SDR306, SS106, SS203, SS303, SSR203, SSR303, SSR306, SVDD303, SVVI103
- Lot or Serial #
- >1000 Lots, Contact Manufacturer
- Reason for Recall
- This is an update of performance and patient management recommendations for a subset of Sigma pacemakers previously recalled because of an increased rate of failure associated with interconnect wire separation caused by a particular cleaning solvent used in manufacturing.
- Trade Name
- Sireskop SX/SD
- Recall Posting Date
- 2009-06-22
- Manufacturer
- Siemens AG
- Recall Start Date
- 2009-02-11
- Recall Number
- 47071
- Hazard Classification
- Type III
- Model or Catalog #
- 10093754, 31 11 676, 3111668
- Lot or Serial #
- 21005, 21040, 21087, 21107, 21110, 31036, 34170, 36103, 41021
- Reason for Recall
- A defective behaviour in data transport layer of the network file system (NFS) connection could cause series as marked successfully archived even though the content is saved sporadically with defective pixel or header data.
- Trade Name
- SmartMonitor 2 Infant Apnea Monitor
- Recall Posting Date
- 2009-05-11
- Manufacturer
- Respironics Inc.
- Recall Start Date
- 2009-04-27
- Recall Number
- 48114
- Hazard Classification
- Type II
- Model or Catalog #
- 4002, 4003
- Lot or Serial #
- S/N: 3000033364 to 3000038740
- Reason for Recall
- A variation in the monitor manufacturing process could expose wires to potential short circuit of the wire leading to the alarm module. This can result in a situation where the alarm will not sound.
- Trade Name
- SmartMonitor 2 Infant Apnea Monitor
Updated recall # 48114 previously posted on 2009-05-11. / Mise à jour du retrait # 48114 affliché le 2009-05-11. - Recall Posting Date
- 2009-06-08
- Manufacturer
- Respironics Inc.
- Recall Start Date
- 2009-04-27
- Recall Number
- 48114
- Hazard Classification
- Type I
- Model or Catalog #
- 4002, 4003
- Lot or Serial #
- S/N: 3000033364 to 3000038740
- Reason for Recall
- A variation in the monitor manufacturing process could expose wires to potential short circuit of the wire leading to the alarm module. This can result in a situation where the alarm will not sound.
- Trade Name
- Steris CMAX Surgical Table Hand Control
- Recall Posting Date
- 2009-06-22
- Manufacturer
- Steris Corporation
- Recall Start Date
- 2009-05-22
- Recall Number
- 48912
- Hazard Classification
- Type III
- Model or Catalog #
- N/A
- Lot or Serial #
- AC001 TO AC0221
- Reason for Recall
- A limited quantity of the CMAX Hand Controls were manufactured without loctite thread locker on the screws that attach the mounting clip to the hand control case. It is possible that screws without the loctite can work loose and the clip can become separated from the hand control. If both screws back out completely, the internal components of the hand control and/or the table control board may become damaged. This could cause a loss of hand functionality.
- Trade Name
- Synchron Phosphorus (PHOSm) Reagent
- Recall Posting Date
- 2009-04-13
- Manufacturer
- Beckman Coulter Inc.
- Recall Start Date
- 2009-04-06
- Recall Number
- 47693
- Hazard Classification
- Type III
- Model or Catalog #
- 467868
- Lot or Serial #
- M808353, M808354
- Reason for Recall
- The Phosphorus Reagent (PHOSm) may fail calibration approximately three to six days after loading on some Synchron systems.
- Trade Name
- Synchron System Total Bilirubin Reagent
- Recall Posting Date
- 2009-04-13
- Manufacturer
- Beckman Coulter Inc.
- Recall Start Date
- 2009-04-06
- Recall Number
- 47692
- Hazard Classification
- Type III
- Model or Catalog #
- 442745, 476861
- Lot or Serial #
- N/A
- Reason for Recall
- A metabolite of naproxen, O-desmethylnaproxen, has demonstrated a positive interference with the Jendrassik-Grof method of measuring Total Bilirubin, leading to spurious elevation in Total Biliruben levels.
- Trade Name
- Synchron Systems Ammonia (AMM) Reagent
- Recall Posting Date
- 2009-05-11
- Manufacturer
- Beckman Coulter Inc.
- Recall Start Date
- 2009-04-08
- Recall Number
- 47835
- Hazard Classification
- Type II
- Model or Catalog #
- 439770
- Lot or Serial #
- M808278
- Reason for Recall
- The ammonia reagent may fail calibration or cause a low shift in quality control recovery (may recover below the limits of the established range) on some Synchron systems.
- Trade Name
- Syngo Dynamics Server Software
- Recall Posting Date
- 2009-05-25
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Recall Start Date
- 2009-03-04
- Recall Number
- 47064
- Hazard Classification
- Type III
- Model or Catalog #
- 100 90 480
- Lot or Serial #
- >10 Numbers, Contact Manufacturer
- Reason for Recall
- There is potential issue in the Syngo Dynamics 5.1 reporting system. Under certain circumstances, when editing text in a report, it may result in additional phrases not populating as expected.
- Trade Name
- Syngo Imaging Update Package VB30A_HF26
- Recall Posting Date
- 2009-05-25
- Manufacturer
- Siemens AG
- Recall Start Date
- 2009-03-04
- Recall Number
- 47067
- Hazard Classification
- Type III
- Model or Catalog #
- 10 014 063
- Lot or Serial #
- 1094, 01200
- Reason for Recall
- Due to several root causes leading to missing or mislinked Performed Procedure Step's some or all studies of a patient may become inaccessible from Syngo studio. With a 3rd party RIS, sometimes "study merge" does not work.
- Trade Name
- TD-Synergy Software On TD-Microbiology
- Recall Posting Date
- 2009-04-27
- Manufacturer
- Technidata S.A.S.
- Recall Start Date
- 2009-04-02
- Recall Number
- 47834
- Hazard Classification
- Type I
- Model or Catalog #
- TD-SYN-01
- Lot or Serial #
- N/A
- Reason for Recall
- MIC (Minimum Inhibitory Concentration) result interpretation can be corrupted and an antibiogram could be reported as sensitive instead of resistant or vice versa.
- Trade Name
- Terumo Advanced Perfusion System 1
- Recall Posting Date
- 2009-06-08
- Manufacturer
- Terumo Cardiovascular Systems Corp.
- Recall Start Date
- 2009-01-12
- Recall Number
- 46050
- Hazard Classification
- Type II
- Model or Catalog #
- 801763
- Lot or Serial #
- 0013, 0017, 0020, 0021, 0144, 0193, 0396, 0601
- Reason for Recall
- Screws in the power manager board may come loose and come into contact with system 1 chassis.
- Trade Name
- TM-400 Broach Handle
- Recall Posting Date
- 2009-06-08
- Manufacturer
- Zimmer Trabecular Metal Technology, Inc.
- Recall Start Date
- 2009-05-08
- Recall Number
- 48453
- Hazard Classification
- Type II
- Model or Catalog #
- 96-210-10001
- Lot or Serial #
- All Lots
- Reason for Recall
- Device may fracture at the threaded tip during use, leaving the broach or trial in the surgical site.
- Trade Name
- TransFx Drill Bit
- Recall Posting Date
- 2009-06-08
- Manufacturer
- Zimmer Inc.
- Recall Start Date
- 2009-05-06
- Recall Number
- 48337
- Hazard Classification
- Type II
- Model or Catalog #
- 00-4450-054-00, 00-4450-056-00,
00-4450-058-00, 00-4450-063-00 - Lot or Serial #
- 56454683, 70196100, 70185600, 70221300, 56454692, 70193000,
70205400 - Reason for Recall
- Device possesses non-conforming tip geometry, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.
- Trade Name
- Triathlon Offset Adaptor Trials
- Recall Posting Date
- 2009-05-25
- Manufacturer
- Howmedica Osteonics Corporation
- Recall Start Date
- 2009-04-22
- Recall Number
- 48074
- Hazard Classification
- Type III
- Model or Catalog #
- 5570-T-020, 5570-T-040, 5570-T-060, 5570-T-080
- Lot or Serial #
- N/A
- Reason for Recall
- Advisory reiterating to customers the potential for the adaptor trial to seize, the preventive maintenance measures, and risk mitigation measures, as stated in the package insert.
- Trade Name
- Truguide Coaxial Biopsy Needle
- Recall Posting Date
- 2009-04-13
- Manufacturer
- Bard Peripheral Vascular, Inc.
- Recall Start Date
- 2009-04-01
- Recall Number
- 47695
- Hazard Classification
- Type II
- Model or Catalog #
- C1410A, C1810B, C1813B, C1816B, C1820B, C2013B, C2016B, C2020B
- Lot or Serial #
- > 10 Numbers, Contact Manufacturer
- Reason for Recall
- Black circle on pouch label for C2013B stated "for use with Bard MaxCore or Monopty Instruments", instead of "for use with MAGNUM Instruments and Biopsy Needles or Biopty Instrument and Biopty-Cut Needles".
- Trade Name
- Unicel DXC 600I Synchron Access Systems
- Recall Posting Date
- 2009-05-11
- Manufacturer
- Beckman Coulter Inc.
- Recall Start Date
- 2009-04-14
- Recall Number
- 47926
- Hazard Classification
- Type III
- Model or Catalog #
- A27318
- Lot or Serial #
- Software V.4.0, Software V.3.0
- Reason for Recall
- If a sample is manually loaded to the access 2I and no program is at the access 2I or DXC console, a program is sent by the LIS only to the DXC console and the sample will not be processed at the access 2I.
- Trade Name
- Update Recall # 35431 previously posted on 2007-06-11.
A) Magic Store System
B) Sienet Magicstore - Recall Posting Date
- 2009-04-27
- Manufacturer
- Siemens AG
- Recall Start Date
- 2007-05-24
- Recall Number
- 35431
- Hazard Classification
- Type III
- Model or Catalog #
- A) 10 014 142, 10 014 154, 10 014 155
B) 8462645 - Lot or Serial #
- A) 3901384286
B) 3904116228, 3904115986 - Reason for Recall
- Hardware component is near end of expected life cycle and the RAID Controller can cause a system crash resulting in a loss of data.
- Trade Name
- Vertier Table Headrest Attachment
- Recall Posting Date
- 2009-06-08
- Manufacturer
- Stryker Communications
- Recall Start Date
- 2009-05-15
- Recall Number
- 48498
- Hazard Classification
- Type II
- Model or Catalog #
- 0788-300-012
- Lot or Serial #
- All Lot Numbers
- Reason for Recall
- The headrest has two pinch points that could result in hospital staff injury during the transportation of the headrest when it is detached from the table.
- Trade Name
- VGM 19" Monitor
- Recall Posting Date
- 2009-05-25
- Manufacturer
- Viewsonic Corporation
- Recall Start Date
- 2009-04-21
- Recall Number
- 48079
- Hazard Classification
- Type II
- Model or Catalog #
- VG930M
- Lot or Serial #
- S/NS > QC2082880001
- Reason for Recall
- 48 complaints reporting that the monitors lost power unexpectedly or when they attempted to power up which resulted in loss of both visual and secondary alarm enunciation from the LCD flat panel.
- Trade Name
- VS Ventilator
- Recall Posting Date
- 2009-06-22
- Manufacturer
- Resmed Paris
- Recall Start Date
- 2009-06-01
- Recall Number
- 48885
- Hazard Classification
- Type III
- Model or Catalog #
- N/A
- Lot or Serial #
- VSU0802002, VSU0802003, VSU0802001, VSU0711510
- Reason for Recall
- Resmed received a report of a failure of a VS Ventilator in Japan that had resulted in a failure of ventilation at start-up. It occurred within a hospital environment.
- Trade Name
- Vumax Ophthalmic Ultrasound Scanner
- Recall Posting Date
- 2009-05-11
- Manufacturer
- Sonomed Inc.
- Recall Start Date
- 2009-04-13
- Recall Number
- 47987
- Hazard Classification
- Type II
- Model or Catalog #
- SHFS35-S
- Lot or Serial #
- 3550-0207-0178, 3550-0108-0244, 3550-0207-0177, 3550-0408-0258, 3550-0707-0213, 3550-0707-0215, 3550-0708-0271, 3550-0907-0220, 3550-0908-0277, 3550-0908-0278, 3550-0108-0252, 3550-0207-0179, 3550-1106-0147, 3550-1106-0148
- Reason for Recall
- The Vumax Ophthalmic Ultrasound System may, under certain circumstances, return measurement values on the order of 1/2 or 2x the actual value. Root cause is a software conflict within software version V2.0.06E.
- Trade Name
- Washer Didinfector Getinge 9027 - 9100
- Recall Posting Date
- 2009-05-11
- Manufacturer
- Getinge Disinfection AB
- Recall Start Date
- 2009-04-20
- Recall Number
- 48035
- Hazard Classification
- Type II
- Model or Catalog #
- 9027, 9100
- Lot or Serial #
- N/A
- Reason for Recall
- The frame earth of the supply transformers for Getinge 9100 and 9027-series Washer Disinfector have burnt out. Result from investigation shows poor connection between incoming and outgoing Protective Earth.
- Trade Name
- Washer Disinfectors With Transformer
- Recall Posting Date
- 2009-06-22
- Manufacturer
- Getinge Disinfection AB
- Recall Start Date
- 2009-04-24
- Recall Number
- 48035
- Hazard Classification
- Type II
- Model or Catalog #
- 9027, 9100
- Lot or Serial #
- > 10 Numbers, Contact Manufactuer
- Reason for Recall
- The frame earth of the supply transformers for the Getinge 9100-series Washer Disinfector have burnt out on one installation in Australia.
- Trade Name
- Waste Bottle For ABL7XX And 8XX Flex
- Recall Posting Date
- 2009-05-25
- Manufacturer
- Radiometer Medical APS
- Recall Start Date
- 2009-04-30
- Recall Number
- 48225
- Hazard Classification
- Type II
- Model or Catalog #
- D512 (905-590), D513 (905-802)
- Lot or Serial #
- For 905-590/D512 : WR-01, WR-02, WR-03, WS-01, WS-02, WS-03, WU-02, WU-03
For 905-802/D513 : WR-01, WR-02, WR-03, WR-04, WS-01, WS-02, WS-03, WS-04, WU-01, WU-02, WU-03, WU-04, WU-05, WU-06, WY-01 - Reason for Recall
- When removing the waste bottle from the analyzer, waste material may leak both from the analyzer and from the waste bottle. This leakage is due to clogged vent holes creating over pressure in the bottle.
- Trade Name
- Wizard Replacement Gastrostomy Device
- Recall Posting Date
- 2009-04-27
- Manufacturer
- Bard Access Systems, Inc.
- Recall Start Date
- 2009-01-16
- Recall Number
- 46066
- Hazard Classification
- Type II
- Model or Catalog #
- 00201W, 00202W, 00204W, 00205W, 00207W, 00214W, 00215W, 00223W, 00224W
- Lot or Serial #
- > 10 Numbers, Contact Manufacturer
- Reason for Recall
- Difficulty inserting or removing the feeding adapter cannula into the device.
- Trade Name
- XIO Radiation Treatment Planning System
- Recall Posting Date
- 2009-06-08
- Manufacturer
- Computerized Medical Systems
- Recall Start Date
- 2009-05-05
- Recall Number
- 48447
- Hazard Classification
- Type II
- Model or Catalog #
- N/A
- Lot or Serial #
- Versions 4.3.0 to 4.40.0
- Reason for Recall
- When beams are renumbered, it is possible to get into a state where the dose displayed for a beam does not match the beam placement on the patient.
- Trade Name
- ZMR Hip System-Stems
- Recall Posting Date
- 2009-06-22
- Manufacturer
- Zimmer Inc.
- Recall Start Date
- 2009-05-27
- Recall Number
- 48913
- Hazard Classification
- Type II
- Model or Catalog #
- 00-9982-015-18
- Lot or Serial #
- 60698102
- Reason for Recall
- The stem threads on some units in this lot may be nonconforming, preventing the compression nut from engaging on the stem.
