BEUDAMED
    FDA Recall Terminated

    Physio-Control LIFEPAK 20 defibrillator/monitor. This product is an external defibrillator sold internationally and domestically.

    Recall: Z-2009-2008 · Initiated May 13, 2008

    Recall

    Recall Number
    Z-2009-2008
    Event Number
    48139
    Firm
    Physio Control, Inc.
    FEI Number
    3015876
    Product Code
    LDD
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 13, 2008
    Posted
    September 8, 2008
    Terminated
    March 20, 2011
    Address
    11811 Willows Rd Ne, Redmond, WA, 98052-2003

    Description

    Physio-Control LIFEPAK 20 defibrillator/monitor. This product is an external defibrillator sold internationally and domestically.

    Reason

    A thicker keypad may prevent the door from fully latching closed. If the door is not fully closed, there is a potential that the defibrillator will not automatically change from automatic external defibrillation (AED) mode to manual mode by pressing the "MANUAL" button located on the lower left corner of the door. This may lead to a delay in defibrillation therapy.

    Action

    On 5/13/08, the firm sent out letters to their domestic customers via Certified Receipt. The letter advised customers of the recall and instructed them to do the following, "Keep the defibrillator in service. If pressing the MANUAL button does not take the defibrillator out of AED mode, press one of the following keys to select manual mode: "ENERGY SELECT", "CHARGE", "PACER", OR "LEAD"... Please call your local Physio-Control service representative to arrange a service visit to replace the keypads." If you have questions, contact Technical Support at 1-800-442-1142, option 5.

    Distribution

    Product distributed to 1 US embassy, 97 domestic medical facilities nationwide, and 5 foreign consignees including the following countries: Germany, Netherlands, Canada, Australia and Hong Kong.

    Quantity

    1,219 units