BEUDAMED
    FDA Recall Terminated

    LIFEPAK 20 automatic external defibrillator

    Recall: Z-0295-2007 · Initiated March 16, 2006

    Recall

    Recall Number
    Z-0295-2007
    Event Number
    36493
    Firm
    Medtronic Emergency Response Systems, Inc.
    FEI Number
    3015876
    Product Code
    LDD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 16, 2006
    Posted
    December 19, 2006
    Terminated
    March 29, 2011
    Address
    11811 Willows Rd Ne, Redmond, WA, 98052-2003

    Description

    LIFEPAK 20 automatic external defibrillator

    Reason

    LIFEPAK 20 may lock-up when attempting to power-up on DC within 2 seconds after removing AC power.

    Action

    Letter dated December 2006 alerts users to the lock-up problem, and suggesting a procedure to prevent lock-up. Firm promised another letter in January 2007 detailing the plan to provide software upgrade.

    Distribution

    Devices were distributed to hospitals and clinics worldwide.

    Quantity

    10,307 devices as of 9-19-06