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Showing 89481–89500 of 92409 results

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Abiomed, Inc.: BVS 5000t Bi-Ventricular Support System Transport/Backup ...

Bi-Ventricular support system may switch to battery when primary voltage (AC) is available

FDAAug 19, 2003Nationwide• Abiomed, Inc.

U & I America: Optima Large Poly Screw Driver

Reports of pieces chipping off the tip of screwdriver during use.

FDAAug 18, 2003MN• U & I America

Wright Medical Technology Inc: Alumina ceramic liner for acetabular shell. This is part...

Wright Medical commercially distributed Transcend alumina acetabular shell liners lacking the required process validation.

FDAAug 18, 2003Nationwide• Wright Medical Technology Inc

Cryolife Inc: CryoValve, Pulmonary Valve & Conduit SG

The heart valve procurement exceeded the warm ischemic time criteria.

FDAAug 18, 2003CA, IN• Cryolife Inc

Beckman Coulter Inc: Vigil Lipid Control, Levels 1,2,3 and 4 for ApoB Reagent.

Values for ApoB were not properly assigned on the package insert. Customers were not able to recover the analyte within the stated values.

FDAAug 18, 2003Nationwide• Beckman Coulter Inc

U & I America: Optima Poly Screw Driver.

Reports of pieces chipping off the tip of screwdriver during use.

FDAAug 18, 2003MN• U & I America

Beckman Coulter Inc: Vigil Lipid Control Serum, Levels 1, 2 and 4 for LDL Chol...

LDL Cholesterol component in controls are unstable.

FDAAug 15, 2003Nationwide• Beckman Coulter Inc

Misonix, Inc: LySonix 2000 Ultrasonic Surgical Systems, MODEL NO. LY-20...

Firm received complaints of tingling or static shock sensation to end users caused by forcing the output connector into its receptacle misaligned. The misalignment causes additional voltage to appear on the patient probe.

FDAAug 13, 2003Nationwide• Misonix, Inc

Ciba Vision Corporation: Quick Care Starting Solution. The product is used for cl...

Investigation has determined that the concentration of the isopropyl alcohol (IPA) decreased over time and may fall below specifications prior to reaching the expiration date.

FDAAug 13, 2003CA, CT, FL +7 more• Ciba Vision Corporation

Terumo Cardiovascular Systems Corp: Terumo Advanced Perfusion System 1; 100V -120V, 15 A (cir...

The central control monitor screen may go blank during use because of a bad wiring connection in the wiring harness or a low voltage setting on the potentiometer.

FDAAug 12, 2003Nationwide• Terumo Cardiovascular Systems Corp

Misys Healthcare Systems: Calculator/Data Processing Module for Clinical Use

Software defect. Clinical Laboratory results failing quality assurance were filed directly to a patient's chart without review.

FDAAug 12, 2003Nationwide• Misys Healthcare Systems

Medstone International Inc: URO PRO Plus Digital Urology Imaging System

X-ray tube arm and collimator fell and fractured patient's ribs.

FDAAug 11, 2003CA, NV, NM +1 more• Medstone International Inc

Harvard Clinical Technology: Software Versions V1.2R,or earlier for the Harvard 2, Dua...

Under specific sequence conditions, the unit may apper to be infusing, but is not

FDAAug 11, 2003Nationwide• Harvard Clinical Technology

Becton Dickinson & Co.: BBL (TM) LIM Broth, in glass slant tubes and packaged 100...

Broth for growing selective bacteria may fail to inhibit overgrowth of gram negative microorganisms resulting in the inability to isolate Group B Streptococci.

FDAAug 11, 2003IN• Becton Dickinson & Co.

Philips Medical Systems Sales & Service Region No. America: Diagnost 94

Potential for table to move by itself

FDAAug 10, 2003Nationwide• Philips Medical Systems Sales & Service Region No. America

Philips Medical Systems Sales & Service Region No. America: Diagnost 97

Potential for table to move by itself

FDAAug 10, 2003Nationwide• Philips Medical Systems Sales & Service Region No. America

Philips Medical Systems Sales & Service Region No. America: Diagnost 96

Potential for table to move by itself

FDAAug 10, 2003Nationwide• Philips Medical Systems Sales & Service Region No. America

Siemens Medical Solutions USA, Inc: Urology X-Ray System, Uroskop D1/D2/D3 - Hardware for Mot...

possible movement of table tilt and table longitudinal

FDAAug 8, 2003Nationwide• Siemens Medical Solutions USA, Inc

Hill-Rom Co., Inc.: Integris Monitor Arm; model P997-04

The monitor may separate from the monitor arm, allowing the monitor to fall from the arm.

FDAAug 8, 2003Nationwide• Hill-Rom Co., Inc.

Terumo Cardiovascular Systems Corp: Sarns brand Retrograde Cardioplegia Cannula, 17 Fr, steer...

Product is labeled as sterile, but inadequate package seal results in lack of assurance of sterility.

FDAAug 8, 2003Nationwide• Terumo Cardiovascular Systems Corp

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