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Showing 18061–18080 of 22584 results

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AGFA Corp.: IMPAX 4.1, IMPAX 4.5, IMPAX 5.0, IMPAX 5.1 IMPAX 5.2,...

Java version 1.6x (JAVA 6) is not compatible with AGFA IMPAX Administration/Service Tools. Due to a Software Mismatch data can be lost.

FDAMay 14, 2007Nationwide• AGFA Corp.

Resonance Technology Inc: Headset Model Number RTC-551-070 for use with the Serene ...

Potential safety concerns - Use of this product with a MRI may result in the headset's cord overheating and patients experiencing burns to the skin.

FDAMay 14, 2007Nationwide• Resonance Technology Inc

Intuitive Surgical, Inc.: daVinci S Surgical system, patient side cart Auxiliary po...

Product may malfunction and fail to start up on AC power.

FDAMay 14, 2007Nationwide• Intuitive Surgical, Inc.

Power Medical Interventions, Inc: Power Linear Cutter Reusable Digital Loading Units with R...

Malfunction - improper staple formation

FDAMay 12, 2007FL, GA, IN +2 more• Power Medical Interventions, Inc

Hawaii Medical LLC: NeatNick Sweeping Action Heel Lancet -Full-Term- Item Num...

Lancet may misfire and an inadequate blood sample may result; additionally, the blade may not retract after use and result in a needle stick to the user/patient

FDAMay 11, 2007Nationwide• Hawaii Medical LLC

Abbott Laboratories: Abbott CELL-DYN 3000 Hematology Analyzer

The product failed electrostatic discharge testing, which could result in product failure.

FDAMay 11, 2007PR• Abbott Laboratories

Abbott Laboratories: Abbott CELL-DYN 3500 Hematology Analyzer

The product failed electrostatic discharge testing, which could result in product failure.

FDAMay 11, 2007PR• Abbott Laboratories

Abbott Laboratories: Abbott CELL-DYN 3700 Hematology Analyzer

The product failed electrostatic discharge testing, which could result in product failure.

FDAMay 11, 2007PR• Abbott Laboratories

Stryker Howmedica Osteonics Corp.: ReUnion Fracture Stem Humeral Component - PureFix HA; Sho...

The plasma spray may delaminate from the proximal portion of the humeral stem.

FDAMay 9, 2007IN, OH• Stryker Howmedica Osteonics Corp.

Humagen Fertility Diagnostics, Inc.: IVF Pasteur Pipettes, glass, cotton plugged, length 9", ...

Pasteur pipettes for laboratory use were labeled as sterile but may have become contaminated.

FDAMay 8, 2007IL, IN• Humagen Fertility Diagnostics, Inc.

Diagnostica Stago, Inc.: STA Liatest Free Protein S For in vitro diagnostic use. 2...

Specific lots of STA Liatest Free Protein S may result in low results in the assigned value ranges and sometimes outside the lower limit.

FDAMay 8, 2007Nationwide• Diagnostica Stago, Inc.

Datascope Corporation: Precision Bipolar Device ClearGlide EVH Small (endoscopic...

Datascope has experienced a higher than usual number of reports involving the Precision Bipolar Device. Reports include the locking or sticking of the buttons of the device which operate the jaws, particularly when a side load is placed on the shaft of the device.

FDAMay 7, 2007Nationwide• Datascope Corporation

Datascope Corporation: Precision Bipolar Device 6 pack Consists of a six-pack of...

Datascope has experienced a higher than usual number of reports involving the Precision Bipolar Device. Reports include the locking or sticking of the buttons of the device which operate the jaws, particularly when a side load is placed on the shaft of the device.

FDAMay 7, 2007Nationwide• Datascope Corporation

Stryker Medical Div. of Stryker Corporation: Stryker Medical -Wheeled Electric Stretcher, Model 1550 (...

The internal power cord may become damaged due to wear and, if this occurs, a shock hazard exists.

FDAMay 7, 2007Nationwide• Stryker Medical Div. of Stryker Corporation

Datascope Corporation: The ClearGlide EVH small with Scissors. The kit includes ...

Datascope has experienced a higher than usual number of reports involving the Precision Bipolar Device. Reports include the locking or sticking of the buttons of the device which operate the jaws, particularly when a side load is placed on the shaft of the device.

FDAMay 7, 2007Nationwide• Datascope Corporation

Beckman Coulter Inc: Cytomics FC 500 Flow Cytometry System with CXP Software V...

Incorrect Display: In certain modes, the protocol will not initially display the correct data in some plots. In addition, when running EWL files, any edited SampleID1 is not automatically updated in all tubes in the panel.

FDAMay 4, 2007Nationwide• Beckman Coulter Inc

Integra LifeSciences Corp.: Endura No-React Dural Substitute 2 cm x 10 cm

Integra LifeSciences Corporation d/b/a Integra NeuroSciences, the distributor of EnDura No-React Dural Substitute, manufactured by Shelhigh, Inc., Union, NJ, is recalling this product based on an FDA Public Health Notification and FDA requested recall letter to Shelhigh citing sterility and other manufacturing concerns regarding this product manufactured by Shelhigh. Integra is a distributor of t

FDAMay 4, 2007Nationwide• Integra LifeSciences Corp.

Intuitive Surgical, Inc.: Endoscopic Instrument Control System (da Vinci Surgical S...

Under certain circumstances, the product's software may crash and require a manual override or restart before functioning again. In addition, there is an unrelated addendum to the User Manual to clarify an icon not described in the previous User Manual.

FDAMay 3, 2007Nationwide• Intuitive Surgical, Inc.

Ross Products Division Abbott Laboratories: Patrol enteral pump set with piercing pin, list #520540.

The enteral pump set may have a 1-3 mm slit in the silicone tubing located between the blue connector and the stretch band Safe-T-Valve.

FDAMay 2, 2007Nationwide• Ross Products Division Abbott Laboratories

Siemens Medical Solutions USA, Inc: Sienet MagicStore. Radiological Digital Image Communicati...

System could crash and result in data loss.

FDAMay 2, 2007CA, CO, FL +6 more• Siemens Medical Solutions USA, Inc

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