BEUDAMED
    FDA Recall Terminated

    Physio-Control LIFEPAK 20 defibrillator/monitor, AC powered external defibrillator with battery backup. Part Numbers: 3202487-073, 3202487-079, 3202488-036, Physio Control, Inc, Redmond, WA 98052

    Recall: Z-1050-2008 · Initiated January 8, 2008

    Recall

    Recall Number
    Z-1050-2008
    Event Number
    46351
    Firm
    Physio Control, Inc.
    FEI Number
    3015876
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 8, 2008
    Posted
    March 29, 2008
    Terminated
    September 4, 2013
    Address
    11811 Willows Rd Ne, Redmond, WA, 98052-2003

    Description

    Physio-Control LIFEPAK 20 defibrillator/monitor, AC powered external defibrillator with battery backup. Part Numbers: 3202487-073, 3202487-079, 3202488-036, Physio Control, Inc, Redmond, WA 98052

    Reason

    Inoperable Device - Potential for delay in therapy or prevention of defibrillation therapy due to corrosion of the Printed Circuit Board Assemblies (PCBA).

    Action

    The firm contacted Customers by phone and by Urgent-Medical Device Recall letters sent via return receipt requested to their consignees on 1/8/08. The letter advised consignees that the Printed Circuit Board Assemblies (PCBA) might not meet quality requirements. This manufacturing deviation could lead to eventual PCBA corrosion that could render the device inoperative and not ready for use in an emergency under battery power. The firm recommended keeping the unit in service until it could be replaced. Representatives will visit each consignee and replace units.

    Distribution

    Worldwide Distribution --- USA including states of OK, SC, TX, and WA, and country of Germany.

    Quantity

    103 total devices - 84 domestic, 19 international