BEUDAMED
    FDA Recall Terminated

    LIFEPAK 20 defibrillator/monitor. The device is an AC powered defibrillator device with battery backup. The defibrillators are primarily used by healthcare providers in device user facilities such as hospitals and clinics.

    Recall: Z-0925-2007 · Initiated April 27, 2007

    Recall

    Recall Number
    Z-0925-2007
    Event Number
    37864
    Firm
    Medtronic Emergency Response Systems, Inc.
    FEI Number
    3015876
    Product Code
    MJK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 27, 2007
    Posted
    June 9, 2007
    Terminated
    March 23, 2012
    Address
    11811 Willows Rd Ne, Redmond, WA, 98052-2003

    Description

    LIFEPAK 20 defibrillator/monitor. The device is an AC powered defibrillator device with battery backup. The defibrillators are primarily used by healthcare providers in device user facilities such as hospitals and clinics.

    Reason

    White Screen Lock up: LifePak 20 defibrillators with software version 48 or version 52 may experience an intermittent timing issue during the power on sequence. This may lock up the device resulting in the monitor screen going white, and may cause a potential delay or prevention of shock treatment.

    Action

    On 04/27/2007 firm sent letters via return receipt to all domestic and foreign customers. The letter recommends for customers to turn the defibrillator power off and back on to restore normal operation in the event of a white screen condition. In addition, the letter advises that a representative from the firm will contact customer to make arrangements to provide a software upgrade to correct the issue.

    Distribution

    Distribution is Worldwide. Devices are used by healthcare providers in hospital or healthcare clinic settings.

    Quantity

    859 units