BEUDAMED
    FDA Recall Terminated

    Powerheart AED G3 Automated External Defibrillator Model 9300E. Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl Road, Minnetonka, MN 55343-7982.

    Recall: Z-0398-05 · Initiated November 12, 2004

    Recall

    Recall Number
    Z-0398-05
    Event Number
    30704
    Firm
    Cardiac Science, Inc.
    FEI Number
    2112020
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 12, 2004
    Posted
    January 15, 2005
    Terminated
    June 25, 2006
    Address
    5474 Feltl Rd, Minnetonka, MN, 55343-7982

    Description

    Powerheart AED G3 Automated External Defibrillator Model 9300E. Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl Road, Minnetonka, MN 55343-7982.

    Reason

    AEDs may contain an electronic component that does not meet its full operating specifications. The AEDs with this suspect electronic component may not functionn properly and may interfere with the AED's ability to delivery therapy. In the event that charge noise is presrent it will delay the first defibrillation shock in the 3 shock sequence.

    Action

    Cardiac Science will contact customers via telephone to set up a time for Clinical Educator to visit the customer and conduct a field test on each AED. AEDs that fail the field test will be replaced either on the spot or within 24 hours. AEDs failing the test are either removed by the Clinical Educator or are returned to Cardiac Science upon receiving the new AED. Cardiac Science anticipates testing to be done by the end of December 2004.

    Distribution

    Throughout the United States, Canada and Europe.

    Quantity

    2049