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Showing 17901–17920 of 22584 results

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Zinnanti Surgical Design LLC: Bayonet Electrosurgical Pencil. P/N 9560575. The product ...

Bubble Leak Test Failure of sterility barrier, therefore sterility of the device may be compromised

FDAJul 12, 2007Nationwide• Zinnanti Surgical Design LLC

Boston Scientific Target: Boston Scientific 6F Guider Softip XF Guiding Catheter, 6...

Mislabeling: Catheters were found to be mislabeled (90 cm labeled devices actually contains 100 cm length catheter)

FDAJul 11, 2007Nationwide• Boston Scientific Target

Alcon Research, Ltd: Atkinson Retrobulbar Anesthesia Needles, 25 gauge 1 1/2"....

Mislabeled: boxes actually contained Tri-Fact needles

FDAJul 11, 2007CA• Alcon Research, Ltd

Stryker Spine: Stryker Radius Locking Caps, Catalog Number: 486610000, M...

Product dissembled in the tray or prior to being loaded onto the inserter or tightening on the rod

FDAJul 10, 2007AZ, CA, CO +12 more• Stryker Spine

Siemens Medical Solutions USA, Inc.: Siemens, ACUSON Antares, Ultrasound System (Standard and ...

Image errors: A software problem results in on-screen indications (graphics) that lead the user to believe that the patient's right and left and the transducer orientation are oriented the same. This is not the case and the actual patient's right and left are reversed from the on-screen indicators.

FDAJul 10, 2007Nationwide• Siemens Medical Solutions USA, Inc.

MAQUET Inc.: Kion Anesthesia Workstation Maquet Critical Care AB SE-17...

Overcharging of batteries and the release of acid fumes

FDAJul 10, 2007Nationwide• MAQUET Inc.

Siemens Medical Solutions USA, Inc.: Siemens, SONOLINE Antares Ultrasound System, 5.0 Systems ...

Image error: A software problem results in on-screen indications (graphics) that lead the user to believe that the patient's right and left and the transducer orientation are oriented the same. This is not the case and the actual patient's right and left are reversed from the on-screen indicators.

FDAJul 10, 2007Nationwide• Siemens Medical Solutions USA, Inc.

Heraeus Kulzer Inc., Dental Products Division: Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light cu...

The material may solidify in the bottle, and thus be rendered unusable.

FDAJul 9, 2007Nationwide• Heraeus Kulzer Inc., Dental Products Division

Acumed LLC: Smooth or threaded metallic bone fixation fastener. 3.5m...

Product mislabeled. The inner sticky labels for the patient identified the product incorrectly as a Cortical screw (non-locking). The product package was labeled correctly.

FDAJul 9, 2007Nationwide• Acumed LLC

Ge Healthcare: GE Healthcare Voluson E8 ultrasound scanner with Software...

When a spectrum of a Pulsed Wave Doppler shows an angle correction unequal to 0 is reloaded from the archive or the image is sent to a DICOM station, this angle correction is mistakenly disregarded resulting in an underestimation of the flow velocities.

FDAJul 6, 2007Nationwide• Ge Healthcare

GE OEC Medical Systems, Inc: GEHC OEC 9900 ESP-15 Elite C-Arm fluoroscopic X-ray syste...

The Air Kerma Rate displayed value and cumulative air kerma displayed value could exceed the allowable error under certain imaging conditions.

FDAJul 6, 2007Nationwide• GE OEC Medical Systems, Inc

Abbott Laboratories: ARCHITECT Prolactin MasterCheck; a single analyte control...

The Architect Prolactin MasterChecks may not be stable at the recommended storage conditions of 2 to 8 degrees C through the expiration dating (15 months). The MasterChecks may exceed the suggested tolerance limits listed in the Reportable Range/Calibration Verification section in Appendix B of the Architect iSystem Operations Manual.

FDAJul 6, 2007Nationwide• Abbott Laboratories

GE OEC Medical Systems, Inc: GEHC OEC 9800 ESP-15 C-Arm fluoroscopic X-ray system, GE ...

The Air Kerma Rate displayed value and cumulative air kerma displayed value could exceed the allowable error under certain imaging conditions.

FDAJul 6, 2007Nationwide• GE OEC Medical Systems, Inc

Focus Diagnostics Inc: HerpeSelect 1 and 2 Immunoblot IgG Kit, IB0900G Intended...

A small percentage of samples tested in specific lots, the HSV common antigen band appears lighter (less reactive) than the reading control band. Reduced reactivity of the common antigen band may lead to inaccurate interpretation of a sample as negative.

FDAJul 6, 2007CA, CT, IL +2 more• Focus Diagnostics Inc

DeRoyal Lafollette: Assorted non- sterile Tracecarts (with sterile component(...

Packaging failure. Lack of sterility assurance

FDAJul 3, 2007Nationwide• DeRoyal Lafollette

Dade Behring, Inc.: EasyLink Informatics System, software version 3.0, Part N...

Sample ID and Patient results could be associated with the wrong patient

FDAJul 3, 2007AZ, CA, CT +12 more• Dade Behring, Inc.

Pacific Bioscience Lab, Inc.: Clarisonic Skin Care System - A hand held cleansing devic...

Overheating: The handle or charger/cradle can overheat, melting the plastic, which potentially can lead to smoke and fire and has caused mild user burns.

FDAJul 3, 2007IN• Pacific Bioscience Lab, Inc.

DeRoyal Lafollette: Assorted sterile surgical kits/ trays: DeRoyal Neuro Tra...

Packaging failure. Lack of sterility assurance

FDAJul 3, 2007Nationwide• DeRoyal Lafollette

Elekta, Inc.: Leksell Gamma Knife Perfexion, Article #715000. Telether...

Need to modify the closing speed of the shielding doors in the event of an emergency exit

FDAJul 2, 2007AZ, AR, CA +11 more• Elekta, Inc.

Datex Ohmeda, Inc: GE Datex-Ohmeda Neonatal Enhancement for the Engstrom Ca...

Neonatal Flow Sensors supplied for use with the Neonatal Enhancement for the Engstrm Carestation may result in the sensors providing invalid values and alarm messages when exposed to high flow rates.

FDAJul 2, 2007TX• Datex Ohmeda, Inc

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