BEUDAMED
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    Guardian Services, Guardian Software, Part Number 0240-009-430 (Guardian Services) with Part Numbers 0250-003-016, 0250-003-017 and 0250-003-018 (OrthoPad) Intended use of Guardian Services is to act as a medical data backup and disaster recovery plan.

    FDA Recall
    Terminated ·Stryker Imaging·Product code LMB·August 3, 2009

    TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH STOPCOCKS, Item No. 42500-03 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·November 23, 2016

    TRANSPAC IV DISPOSABLE TRANSDUCER WITH STOPCOCKS, Item No. 42500-03 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code DRS·September 27, 2016

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013