BEUDAMED
    FDA Recall Terminated

    LIFEPAK 12 defibrillator/monitor.

    Recall: Z-0938-04 · Initiated April 5, 2004

    Recall

    Recall Number
    Z-0938-04
    Event Number
    28737
    Firm
    Medtronic Physio Control Corp
    FEI Number
    3015876
    Product Code
    LDD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 5, 2004
    Posted
    July 20, 2004
    Terminated
    January 6, 2005
    Address
    11811 Willows Rd NE, Redmond, WA, 98073

    Description

    LIFEPAK 12 defibrillator/monitor.

    Reason

    Potential for display to go blank due to an electrical component that may fail due to mechanical shock of vibration of the defibrillator.

    Action

    Letters dated April 2004 were sent to customers on 4/6/04. The letter explains that a service representative will visit the customer and check the capacitor.

    Distribution

    Devices were distributed to hospitals and medical centers throughout the US. The firm also distributed units internationally.

    Quantity

    2885