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Showing 64141–64160 of 68218 results

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Alcon Laboratories, Inc: Alcon Custom-Pak, part #2638-17, containing BD Beaver Min...

Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for use in custom surgical packs.

FDADec 22, 2006AR, IN, MN +3 more• Alcon Laboratories, Inc

Alcon Laboratories, Inc: Alcon Custom-Pak, part #10975-02, containing BD Beaver Mi...

Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for use in custom surgical packs.

FDADec 22, 2006AR, IN, MN +3 more• Alcon Laboratories, Inc

Stryker Leibinger USA: Stryker Tom Tessier Osseous Microtome: Plug for Bone Mil...

Laceration Risk

Metal shavings come off of the plug as a result of friction between the plug and the cutting cylinder, and may be mixed with the milled bone chips.

FDADec 22, 2006Nationwide• Stryker Leibinger USA

GE Healthcare: GE Discovery VCT, Volume PET-CT scanner, Model 5124069-3.

Oil may leak onto the port window of the CT tube and may result in image artifacts that could lead to misdiagnosis.

FDADec 21, 2006AL, AK, AZ +46 more• GE Healthcare

GE Healthcare: GE LightSpeed VCT / Light Speed VCT standard configuratio...

Oil may leak onto the port window of the CT tube and may result in image artifacts that could lead to misdiagnosis.

FDADec 21, 2006AL, AK, AZ +46 more• GE Healthcare

GE Healthcare: GE LightSpeed Pro 16 (100kW/80kW) Models 2357739, 2357739...

Oil may leak onto the port window of the CT tube and may result in image artifacts that could lead to misdiagnosis.

FDADec 21, 2006AL, AK, AZ +46 more• GE Healthcare

GE Healthcare: GE LightSpeed VCT Select / LightSpeed Pro32, Model 512609...

Oil may leak onto the port window of the CT tube and may result in image artifacts that could lead to misdiagnosis.

FDADec 21, 2006AL, AK, AZ +46 more• GE Healthcare

GE Medical Systems LLC: Definium AMX 700 Digital mobile x-ray system, GE Healthca...

When using the Tech Switch on exposures >750ms, >100 kVp and > 100 mAs the exposure terminates prematurely.

FDADec 21, 2006IN, MS, NE +2 more• GE Medical Systems LLC

GE Healthcare: GE LightSpeed Xtra / GE LightSpeed RT Pro 16, Model 23746...

Oil may leak onto the port window of the CT tube and may result in image artifacts that could lead to misdiagnosis.

FDADec 21, 2006AL, AK, AZ +46 more• GE Healthcare

Cenorin: ThermaSure Medical Device Drying Cabinet, series 130

Potential for user to receive an electrical shock.

FDADec 21, 2006Nationwide• Cenorin

Integrated Orbital Implants Inc: Perry-Kolberg Titanium Motility/Support System (Threaded ...

The threads on the threaded sleeve were manufactured with left-handed threads, requiring a modification to the surgical technique for proper insertion. Failure to properly identify the affected components and apply the modified insertion technique will result in an inability to insert the sleeve into the implant.

FDADec 20, 2006Nationwide• Integrated Orbital Implants Inc

Boston Scientific Corporation One Boston: Wallstent Endoscopic Biliary Endoprosthesis- 8mm x 40mm, ...

Guidewire restriction during use (excessive adhesive in the guidewire lumen)

FDADec 20, 2006Nationwide• Boston Scientific Corporation One Boston

Hospira Inc.: LifeShield Latex-Free Primary I.V. Pump Set with Distal M...

The tubing can separate from the set at the filter inlet post.

FDADec 20, 2006Nationwide• Hospira Inc.

Bard Peripheral Vascular Inc: G2 Filter System - Jugular/Subclavian Delivery Kit, for u...

This action is being taken because BPV has recently received three complaints for the device that involve reports of introducer sheath tip damage. The damage may result in loss of tip integrity.

FDADec 20, 2006Nationwide• Bard Peripheral Vascular Inc

Bard Peripheral Vascular Inc: Recovery G2 Filter System - Jugular/Subclavian Delivery K...

This action is being taken because BPV has recently received three complaints for the device that involve reports of introducer sheath tip damage. The damage may result in loss of tip integrity.

FDADec 20, 2006Nationwide• Bard Peripheral Vascular Inc

bioMerieux, Inc.: BacT/VIEW C.30a Software update (P/N 514515-1) diagnostic...

Bottle data is not sent to BacT/ALERT 3D instrument.

FDADec 19, 2006Nationwide• bioMerieux, Inc.

Toshiba American Med Sys Inc: Nemio XG, ultrasound system, SSA-590A with version 1.5 so...

Transducer Surface Temperature : It was found during testing that when using the system in the 2DCDI + PW mode, with the Scale Graph function active, that the transducer surface temperature could exceed the 27 degrees Celsius limit as specified in the IEC safety standard.

FDADec 19, 2006Nationwide• Toshiba American Med Sys Inc

bioMerieux, Inc.: BacT/VIEW Software, all versions. in vitro diagnostic da...

BacT/VIEW will be unable to run scheduled macro applications unless the user touches the BacT/VIEW touch screen or clicks a function after resynchronizing the clocks.

FDADec 19, 2006Nationwide• bioMerieux, Inc.

Philips Medical Systems: HeartStart FR2+ Defibrillator

Potential for shock treatment to be delayed or prevented due to board contamination that causes intermittent switch operation

FDADec 19, 2006Nationwide• Philips Medical Systems

Medtronic Sofamor Danek Instrument Manufacturing: Rocker Reducer, part of the SiLo Spinal System, REF 88800...

Due to a manufacturing error, the proximal end may deform causing the protrusions that engage the associated implant to break off of the instrument during use.

FDADec 18, 2006Nationwide• Medtronic Sofamor Danek Instrument Manufacturing

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