BEUDAMED
    FDA Recall Terminated

    LIFEPAK 500 automated external defibrillator

    Recall: Z-0886-04 · Initiated April 2, 2004

    Recall

    Recall Number
    Z-0886-04
    Event Number
    28727
    Firm
    Medtronic Physio Control Corp
    FEI Number
    3015876
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 2, 2004
    Posted
    July 20, 2004
    Terminated
    January 6, 2005
    Address
    11811 Willows Rd NE, Redmond, WA, 98073

    Description

    LIFEPAK 500 automated external defibrillator

    Reason

    Potential for batteries to malfunction due to battery cell rupture.

    Action

    On 4/2/04 the firm initiated telephone contacts to customers to determine if the customer potentially has suspect battery. If so, the customer will be faxed a letter describing how to remove the battery to check for the code date. If customer confirms they have suspect battery, a new battery will be shipped to customer.

    Distribution

    The firm distributed devices nationwide to various hospitals, medical centers, and businesses. The firm also distributed to foreign customers in Australia, Argentina, Brazil, Canada, China, Greece, Hong Kong, Israel, India, Jordan, Mexico, Netherlands, New Zealand, Oman, Philippines, Saudi Arabia, United Kingdom.

    Quantity

    7028