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Showing 18461–18480 of 22584 results

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Smith & Nephew, Inc Endoscopy Division: SOPRO Camera Control Units, PAL, SV420P, REF (Catalog) #7...

Surgical camera control units were not designed and manufactured to pass the IEC 60101 testing for electrical fast transients (EFT)

FDAJan 19, 2007Nationwide• Smith & Nephew, Inc Endoscopy Division

Remington Medical Inc.: Prostate Biopsy Needle, Model: NAC-1825BB, Soxe 18 GA x 2...

Pouches were not sealed prior to sterilization.

FDAJan 19, 2007Nationwide• Remington Medical Inc.

Smith & Nephew, Inc. Endoscopy Division: RF Denervation Probe, 15 cm, temperature sensing electrod...

Product is non-sterile but labeled incorrectly as sterile.

FDAJan 19, 2007Nationwide• Smith & Nephew, Inc. Endoscopy Division

Taut, Inc.: Taut Intraducer Peritoneal Catheter, 12 Fr x 10 Fr x 20.3...

Taut, Inc. has become aware that some package seals are not intact, compromising the sterility of the catheters.

FDAJan 19, 2007Nationwide• Taut, Inc.

Smith & Nephew, Inc. Endoscopy Division: RF Denervation Probe, 5cm, temperature sensing electrodes...

Product is non-sterile but labeled incorrectly as sterile.

FDAJan 19, 2007Nationwide• Smith & Nephew, Inc. Endoscopy Division

Beevers Manufacturing & Supply, Inc.: Cannulaide, Model 101. The Cannulaide product is composed...

Cannulaide model CA 101 was recalled because the firm discovered this model was packed and labeled as CA 102.

FDAJan 18, 2007Nationwide• Beevers Manufacturing & Supply, Inc.

Catch Incorporated: Homocysteine Reagent Test Kit. The Homocysteine test ki...

A high homocysteine level can be reported as falsely low.

FDAJan 18, 2007CA, PA• Catch Incorporated

Diagnostica Stago, Inc.: STA Compact and STA Compact CT For in vitro Diagnostic Us...

Result of complaints of field failures of the silicon bridge rectifier, resulting in smoke billowing out of the unit and burnt circuit boards, wires and connectors.

FDAJan 18, 2007Nationwide• Diagnostica Stago, Inc.

Alcon Research, Ltd: 19 Gauge Trocar Cannula Replacement Plug, Catalog Number ...

Product is misbranded; 19 gauge Schlera Plugs distributed in containers labeled as 19 gauge Trochar Canula Plugs.

FDAJan 18, 2007Nationwide• Alcon Research, Ltd

Radiometer America Inc: ABL800 FLEX Series analyzer with FLEXQ module-equipped w...

In some situations pre-registered patient data is not reset when leaving the pre-registration mode in the software. This occurs when a Safe Pico blood sampler associated with a specific patient is pre-registered in the analyzer by scanning a barcode.

FDAJan 16, 2007AL, CA, CO +12 more• Radiometer America Inc

Candela Laser Corporation: Candela Corporation Vbeam Aesthetica Laser System, Model/...

Internal component may overheat causing the possibility of risk of fire or smoke

FDAJan 15, 2007Nationwide• Candela Laser Corporation

Siemens Medical Solutions Diagnostics: Sample Management System software for in vitro diagnostic...

Under limited circumstances, an incorrect patient result could be printed on the optional chartable patient report.

FDAJan 15, 2007Nationwide• Siemens Medical Solutions Diagnostics

Candela Laser Corporation: Candela Corporation Vbeam Perfecta Laser System, Model/Ca...

Internal component may overheat causing the possibility of risk of fire or smoke

FDAJan 15, 2007Nationwide• Candela Laser Corporation

GE OEC Medical Systems, Inc: OEC Uroview 2800 with Dual Monitor Option, fluoroscopic x...

Uroview 2800 system with dual monitors may pose a safety risk to patients if the monitors become disconnected and fall.

FDAJan 15, 2007Nationwide• GE OEC Medical Systems, Inc

Candela Laser Corporation: Candela Corporation Vbeam Platinum Laser System, Model/Ca...

Internal component may overheat causing the possibility of risk of fire or smoke

FDAJan 15, 2007Nationwide• Candela Laser Corporation

GE OEC Medical Systems, Inc: OEC Uroview 2800 fluoroscopic x-ray system with 3 Phase P...

Uroview 2800 system with 3 Phase Power Distribution Box (Wonder Box) option can present a shock hazard to the user if the access door to the power box is not completely closed when the unit is powered on. .

FDAJan 15, 2007Nationwide• GE OEC Medical Systems, Inc

Terumo Cardiovascular Systems Corp: Terumo Perfusion System 8000 Base, 4 pump, 115v; Model 80...

The hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped as replacements for hand cranks recalled in the Summer of 2006.)

FDAJan 12, 2007Nationwide• Terumo Cardiovascular Systems Corp

GE Healthcare Integrated IT Solutions: GE Centricity PACS RA1000 Workstation; for diagnostic ima...

The Centricity PACS RA1000 Workstation Software may manifest certain mammography image display problems only if the images were acquired through GE Senographe versions 2000D, DS or Essential.

FDAJan 12, 2007Nationwide• GE Healthcare Integrated IT Solutions

Elekta, Inc.: Precise Treatment Table Intended as a universal patient ...

In some instances, the bolts which are supplied with the table have sheared off, resulting in inability to operate the powered table.

FDAJan 11, 2007PR• Elekta, Inc.

bioMerieux, Inc.: BacT/ALERT FA Culture Bottles, 30 ml, for in vitro diagno...

Bacillus sp. contamination was detected in inoculated and uninoculated bottles of BacT/ALERT FA Culture bottles.

FDAJan 11, 2007Nationwide• bioMerieux, Inc.

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