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Showing 19541–19560 of 22584 results

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Siemens Medical Solutions USA, Inc: SOMATOM CT System Sensation 16. Computed tomography x-ra...

When using the LungCare feature in the SOMATOM CT Systems some marks made on CT images may not be saved.

FDAMar 9, 2006Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: SOMATOM CT System Sensation Open. Computed tomography x-...

When using the LungCare feature in the SOMATOM CT Systems some marks made on CT images may not be saved.

FDAMar 9, 2006Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: SOMATOM CT System Sensation 40 and Sensation 64. Compute...

When using the LungCare feature in the SOMATOM CT Systems some marks made on CT images may not be saved.

FDAMar 9, 2006Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: SOMATOM CT System Emotion 16. Computed tomography x-ray ...

When using the LungCare feature in the SOMATOM CT Systems some marks made on CT images may not be saved.

FDAMar 9, 2006Nationwide• Siemens Medical Solutions USA, Inc

Abbott Laboratories MPG: ARCHITECT B12 Reagent, list 06C09-22 (4 x 100 tests), 06C...

The 30-day onboard storage information is not included in the barcode labels for these two lots. As a result, the ARCHITECT system software is unable to track how long a reagent kit has been stored onboard the ARCHITECT instrument.

FDAMar 8, 2006Nationwide• Abbott Laboratories MPG

Smiths Medical ASD, Inc.: TTS-400J Level1 Tympanic Temperature Sensor with 400 Seri...

Product temperature readings may be 2C higher than the actual temperature

FDAMar 8, 2006Nationwide• Smiths Medical ASD, Inc.

Advanced Bionics Corporation 12740 San Fernando Rd Bldgs. 1 & 3 Sylmar CA 91342: The unimplanted HiRes90K Implantable Cochlear Stimulator...

Certain HiRes 90K cochlear implants could fail as a result of elevated moisture levels. The unimplanted HiRes 90K implants listed are being removed from the market. Patients are to be followed for signs of device failure: intermittent function, complete loss of sound, sudden discomfort, pain, noise, or popping.

FDAMar 8, 2006Nationwide• Advanced Bionics Corporation 12740 San Fernando Rd Bldgs. 1 & 3 Sylmar CA 91342

Unknown Manufacturer: ev3 Primus GPS Biliary Stent System. Balloon Expandable ...

A Primus device labeled (pouch and box) as a BXB35-05-17-120 contained a 6mm x 20mm catheter instead of the intended 5mm x 20mm catheter.

FDAMar 8, 2006CA, FL, IN +9 more

Smiths Medical ASD, Inc.: STS-400 Level1 Skin Temperature Sensor with 400 Series Th...

Product temperature readings may be 2C higher than the actual temperature

FDAMar 8, 2006Nationwide• Smiths Medical ASD, Inc.

Medtronic Neurosurgery: Medtronic (TiMesh), Screwdriver, 1.5mm, Cruciate, Self Ta...

Medtronic Neurosurgery has initiated this action because it was determined that two lots of the Modular Screwdriver Blade components may exhiibt burrs along the tips of the Screwdriver, which may prevent adequate engagement with the associated screws.

FDAMar 8, 2006FL, IL, NY +2 more• Medtronic Neurosurgery

Instrumentation Laboratory Co.: HemosIL RecombiPlasTin. Prothrombin Time Test. Each Recom...

Firm received 2 complaints concerning incorrect prothrombin time (PT) results while using the reagents on samples of patients taking the antibiotic CUBICIN (Daptomycin for injection).

FDAMar 7, 2006Nationwide• Instrumentation Laboratory Co.

Smiths Medical ASD, Inc.: Blue Line Ultra Tracheostomy Tube 8.00mm Inner Cannula R...

Mislabeled Product labeled as 8.0mm inner cannula, may contain a 9.0mm

FDAMar 7, 2006Nationwide• Smiths Medical ASD, Inc.

Instrumentation Laboratory Co.: Hemoliance RecombiPlasTin. Prothrombin Time Test. The pro...

Firm received 2 complaints concerning incorrect prothrombin time (PT) results while using the reagents on samples of patients taking the antibiotic CUBICIN (Daptomycin for injection).

FDAMar 7, 2006Nationwide• Instrumentation Laboratory Co.

Ortho-Clinical Diagnostics: VITROS WorkCentre, Catalog # 6802159, using enGen" Series...

Incorrect result calculations can occur (only affects derived results calculated by the VITROS WorkCentre)

FDAMar 6, 2006AZ, DE, MI +1 more• Ortho-Clinical Diagnostics

GE Healthcare: GE Healthcare Innova 4100 and Innova 4100 with Bolus Chas...

Incorrect screws were used for mounting the detector which may lead to a possible part falling onto a patient.

FDAMar 6, 2006Nationwide• GE Healthcare

GE Healthcare: GE Healthcare Innova 3100 and Innova 3100 with Bolus Chas...

Incorrect screws were used for mounting the detector which may lead to a possible part falling onto a patient.

FDAMar 6, 2006Nationwide• GE Healthcare

Boston Scientific Target: iLab Utrasound Imaging System, software controlled Imagin...

Using the product for procedures that exceed manual record mode may result in inadvertent needle stick to myocardium or blood vessel. (with ICE intracardiac imaging catheters only)

FDAMar 6, 2006Nationwide• Boston Scientific Target

GE Healthcare: GE Medical Systems Innova 2000 and Innova 2000S, and Inno...

Incorrect screws were used for mounting the detector which may lead to a possible part falling onto a patient.

FDAMar 6, 2006Nationwide• GE Healthcare

Kerr Corp: Tooth bonding resin. Premise Master Syringe Kit, Part Num...

The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance.

FDAMar 3, 2006Nationwide• Kerr Corp

Kerr Corp: Tooth bonding resin. Optibond Solo Plus, Part Number 3151...

The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance.

FDAMar 3, 2006Nationwide• Kerr Corp

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