BEUDAMED
    FDA Recall Terminated

    Zoll AED Plus Defibrillator (Automatic External Defibrillator)

    Recall: Z-0548-03 · Initiated December 17, 2002

    Recall

    Recall Number
    Z-0548-03
    Event Number
    25245
    Firm
    Zoll Medical Corporation
    FEI Number
    1220908
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 17, 2002
    Posted
    February 6, 2003
    Terminated
    April 21, 2004
    Address
    32 Second Avenue, Burlington, MA, 01803

    Description

    Zoll AED Plus Defibrillator (Automatic External Defibrillator)

    Reason

    Defibrillator may fail to function due to false detection of safety fault condition

    Action

    Zoll Medical notified Direct accounts by letter issued Overnight Certified Mail on 12/17/02 to Domestic Accounts and 12/18/02 to International accounts.

    Distribution

    Nationwide to : Hospitals, EMT, Police and Fire Rescue

    Quantity

    5,597 units