BEUDAMED
    FDA Recall Terminated

    Physio-Control Lifepak 20 defibrillator/monitor is intended for the termination of certain fatal arrhythmias.

    Recall: Z-2388-2008 · Initiated June 18, 2008

    Recall

    Recall Number
    Z-2388-2008
    Event Number
    48748
    Firm
    Physio Control, Inc.
    FEI Number
    3015876
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 18, 2008
    Posted
    September 21, 2008
    Terminated
    September 4, 2013
    Address
    11811 Willows Rd Ne, Redmond, WA, 98052-2003

    Description

    Physio-Control Lifepak 20 defibrillator/monitor is intended for the termination of certain fatal arrhythmias.

    Reason

    Potential for the coin battery to drain prematurely causing the monitor clock time and date to be incorrect and the service light indicator to illuminate.

    Action

    On 06/18/08 the firm, via regular postal service , mailed an "IMPORTANT MEDICAL DEVICE NOTIFICATION" letter to all their consignees. The letter instructs consignees that the coin battery may deplete prematurely and to contact Physio-Control if their Lifepack 20 defibrillator/monitor requires coin battery replacement prior to the recommended four year replacement schedule. If you have any questions, contact Technical Support at 1-800-442-1142, option 5 from 6:00 am to 4:00 pm (Pacific), Monday-Friday or visit www.physio-control-notices.com/coin battery.

    Distribution

    There were 24,238 devices distributed to 3,135 consignees throughout the United States and 20,613 devices distributed to 48 foreign consignees.

    Quantity

    45,209 devices