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Showing 18521–18540 of 22584 results

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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 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

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

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

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

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

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.

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

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.

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

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

Terang Nusa Sdn Bhd 1, Jalan 8, Pengkalan Chepa 2, Ind Zone Kota Bharu Malaysia: Sterile Neolon 2G Latex-Free Powder-Free Neoprene Surgica...

Some of the packages labeled as latex-free actually contain latex gloves.

FDADec 18, 2006Nationwide• Terang Nusa Sdn Bhd 1, Jalan 8, Pengkalan Chepa 2, Ind Zone Kota Bharu Malaysia

The Anspach Effort, Inc.: Anspach MicroMax Pneumatic Motor System; ENT Surgical Dri...

Incorrect Sterilization Process --The Operating Manual for the product contains an incorrect statement regarding the sterilization of the Autolube foot control. The manual states that the product can withstand ETO sterilization, but there is no data to support this process.

FDADec 18, 2006Nationwide• The Anspach Effort, Inc.

The Anspach Effort, Inc.: Anspach BlackMax Pneumatic Motor System; ENT Surgical Dri...

Incorrect Sterilization Process --The Operating Manual for the product contains an incorrect statement regarding the sterilization of the Autolube foot control. The manual states that the product can withstand ETO sterilization, but there is no data to support this process.

FDADec 18, 2006Nationwide• The Anspach Effort, Inc.

The Anspach Effort, Inc.: Anspach Xmax Pneumatic Motor System; ENT Surgical Drill, ...

Incorrect Sterilization Process --The Operating Manual for the product contains an incorrect statement regarding the sterilization of the Autolube foot control. The manual states that the product can withstand ETO sterilization, but there is no data to support this process.

FDADec 18, 2006Nationwide• The Anspach Effort, Inc.

Abbott Diabetes Care, Inc.: Abbott Precision Link Software (Version 2.1), (Version 2....

If the time and date are not set correctly on both the user's meter and computer, there is the potential for incorrect times and dates to be assigned to the results in the Precision Link Software.

FDADec 18, 2006PR• Abbott Diabetes Care, Inc.

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

Suros Surgical Systems Inc.: Suros ATEC Breast Biopsy System handpiece (9 gauge cannul...

The handpiece package may have an incorrect part number on the inner package. Error could result in over-penetration of the biopsy needle.

FDADec 15, 2006Nationwide• Suros Surgical Systems Inc.

Smiths Medical ASD, Inc.: Bivona Laryngectomy Tube, Cuffless, Silicone, I.D. 9.5 mm...

The label incorrectly states the outer diameter of the tube is 20.0 mm when it is actually 12.0 mm.

FDADec 15, 2006Nationwide• Smiths Medical ASD, Inc.

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