BEUDAMED
    FDA Recall Terminated

    Medtronic Physio-Control LIFEPAK CR Plus Defibrillator/Monitor. Automated external defibrillator deployed primarily in public access defibrillator environments where the expected use for any one device is once every 20 months. For use on persons requiring defibrillation therapy.

    Recall: Z-2030-2009 · Initiated July 31, 2009

    Recall

    Recall Number
    Z-2030-2009
    Event Number
    53035
    Firm
    Physio Control, Inc.
    FEI Number
    3015876
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 31, 2009
    Posted
    September 14, 2009
    Terminated
    March 15, 2013
    Address
    11811 Willows Rd Ne, Redmond, WA, 98052-2003

    Description

    Medtronic Physio-Control LIFEPAK CR Plus Defibrillator/Monitor. Automated external defibrillator deployed primarily in public access defibrillator environments where the expected use for any one device is once every 20 months. For use on persons requiring defibrillation therapy.

    Reason

    The K1 relay on the Analog printed circuit board assembly may short due to moisture ingress in a highly humid environment. K1 shorting may affect the ECG amplitude causing the Shock Advisory System(SAS) to not analyze the ECG rhythm correctly thus preventing the device from delivering therapy.

    Action

    Physio-Control, Inc. notified Customers by phone beginning August 18, 2009. In addition, the recalling firm Issued an "Urgent Medical Device Recall" letter dated August 2009 informing Customers of the affected product and informing them that a Physio-Control representative will call and arrange for immediate device replacement. For further information, contact Physio-Control Customer Care at 1-800-442-1142.

    Distribution

    Worldwide Distribution -- US (DC and MN) and Japan.

    Quantity

    34 devices (2 domestically & 32 internationally)