BEUDAMED
    FDA Recall Terminated

    LIFEPAK 20 defbrillator/monitor

    Recall: Z-0984-05 · Initiated June 17, 2005

    Recall

    Recall Number
    Z-0984-05
    Event Number
    32492
    Firm
    Medtronic Emergency Response Systems, Inc.
    FEI Number
    3015876
    Product Code
    LDD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 17, 2005
    Posted
    July 13, 2005
    Terminated
    May 6, 2006
    Address
    11811 Willows Rd Ne, Redmond, WA, 98052-2003

    Description

    LIFEPAK 20 defbrillator/monitor

    Reason

    The defibrillator may not operate if the device is turned on during an AC Loss Alert.

    Action

    On 6/17/05 the firm issued a medical device correction letter to customers advising of the problem, explained what to do if the situation occurs, and that a service representative will visit and install new software.

    Distribution

    Devices were distributed to hospitals and medical centers worldwide.

    Quantity

    3924 units