BEUDAMED
    FDA Recall Terminated

    Power Heart Automatic External Defibrillator, Model 9210 RD

    Recall: Z-1034-04 · Initiated May 24, 2004

    Recall

    Recall Number
    Z-1034-04
    Event Number
    29024
    Firm
    Cardiac Science, Inc.
    FEI Number
    2112020
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 24, 2004
    Posted
    July 20, 2004
    Terminated
    November 18, 2005
    Address
    5474 Feltl Rd., Minneapolis, MN, 55343-7982

    Description

    Power Heart Automatic External Defibrillator, Model 9210 RD

    Reason

    Some of the high voltage capacitors in the recalled external defibrillators have had extended charge times resulting in self-test failures following which the defibrillator cannot be used/cannot be turn on.

    Action

    A recall letter, dated May 24, 2004, stated that a replacement AED is enclosed with the letter, and instructed consignees to replace their AED with the new one immediately and return the old AED.

    Distribution

    The recalled AED units were distributed nationwide in the United States and to foreign accounts in Europe, Asia, Latin America, the Middle East, and Africa.