BEUDAMED
    FDA Recall Terminated

    The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators. Product part's numbers: 3200731-xxx, 3202177-xxx, U3200731-xxx, and U3202177-006. Automated external defibrillators.

    Recall: Z-1082-2013 · Initiated February 8, 2013

    Recall

    Recall Number
    Z-1082-2013
    Event Number
    64427
    Firm
    Physio Control, Inc.
    FEI Number
    3015876
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    February 8, 2013
    Posted
    April 10, 2013
    Terminated
    November 5, 2015
    Address
    11811 Willows Rd Ne, Redmond, WA, 98052-2003

    Description

    The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators. Product part's numbers: 3200731-xxx, 3202177-xxx, U3200731-xxx, and U3202177-006. Automated external defibrillators.

    Reason

    LIFEPAK CR Plus or LIFEPAK Express Automated External Defibrillators (AEDs) are recalled due to the potential to experience an early internal battery depletion issue.

    Action

    The firm start sending the "URGENT MEDICAL DEVICE CORRECTION LIFEPAK CR Plus AND LIFEPAK EXPRESS AEDs" letter, dated February 2013, to their consignees. Consignees are advised to check the readiness of the AEDs and should contact Physio if the OK symbol is NOT visible and either the ATTENTION or WRENCH symbols are present. In the event a device is returned to Physio-Control for assessment, the firm will analyze it to determine if it is affected by the early internal battery depletion issue. If it is verified the device is affected, the consignee will be provided with a permanent replacement device. Customers with questions can visit the firm's website www.physio-control-notices.com/CHARGE-PAK or call Technical Support at 1-800-442-1142.

    Distribution

    Worldwide Distribution.

    Quantity

    54,197 units in US and 78,627 units internationally (total 132, 824 units)