BEUDAMED
    FDA Recall Terminated

    LIFEPAK CR Plus defibrillator

    Recall: Z-0940-03 · Initiated May 23, 2003

    Recall

    Recall Number
    Z-0940-03
    Event Number
    26358
    Firm
    Medtronic Physio Control Corp
    FEI Number
    3015876
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 23, 2003
    Posted
    June 12, 2003
    Terminated
    February 24, 2004
    Address
    11811 Willows Rd NE, Redmond, WA, 98073

    Description

    LIFEPAK CR Plus defibrillator

    Reason

    Defibrillation therapy may be delayed or not delivered for persons needing defibrillation therapy.

    Action

    On 5/23/03, the firm issued a recall letter to customers advising of the malfunctions and instructions to check the device to assure it is ready for use. Service representatives will visit the customer sites and replace the flex circuit in all affected devices.

    Distribution

    The firm distributed units worldwide. Foreign distribution includes Australia, Canada, Costa Rica, Hong Kong, India, Israel, Jamaica, Netherlands, New Zealand, Saudi Arabia, South Africa, Uruguay.

    Quantity

    7095 devices