BEUDAMED
    FDA Recall Terminated

    Power Heart AED G3 Automated External Defibrillator IntelliSense (Lithium) Battery, Model 9142

    Recall: Z-0990-04 · Initiated May 4, 2004

    Recall

    Recall Number
    Z-0990-04
    Event Number
    29026
    Firm
    Cardiac Science, Inc.
    FEI Number
    2112020
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 4, 2004
    Posted
    July 20, 2004
    Terminated
    November 18, 2005
    Address
    1900 Main Street, Suite 700, Irvine, CA, 92614

    Description

    Power Heart AED G3 Automated External Defibrillator IntelliSense (Lithium) Battery, Model 9142

    Reason

    Some of the recalled defibrillator batteries contain an incorrect fuse which could open resulting in a defibrillator which will not work.

    Action

    A recall letter, dated May 10, 2004, stated that a replacement battery is enclosed with the letter, and instructed consignees to install the new battery in their defibrilllator and return the old battery.

    Distribution

    The batteries were distributed with the defibrillators nationwide in the United States and to foreign consignees in Europe, Asia, Latin America, the Middle East and Africa.