BEUDAMED
    FDA Recall Terminated

    LIFEPAK 20 defibrillator/monitor

    Recall: Z-0711-06 · Initiated March 22, 2006

    Recall

    Recall Number
    Z-0711-06
    Event Number
    34947
    Firm
    Medtronic Emergency Response Systems, Inc.
    FEI Number
    3015876
    Product Code
    LDD
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 22, 2006
    Posted
    April 4, 2006
    Terminated
    September 6, 2011
    Address
    11811 Willows Rd Ne, Redmond, WA, 98052-2003

    Description

    LIFEPAK 20 defibrillator/monitor

    Reason

    Therapy connectors may have connector sockets that do not meet design specs - short drill depth. Interruption of the connections may cause unexpected, intermittent or complete loss of pacing and defibrillation functions.

    Action

    On 3/22/06, the firm began sending out letters dated March 2006, and flagged URGENT MEDICAL DEVICE CORRECTION. The letters advised customers of the issue and that a service representative would visit and inspect the therapy connector sockets, and replace the therapy connector and the mating cable if short drill sockets are found.

    Distribution

    Nationwide, and Canada, Netherlands, Germany, Australia, Guam, Hong Kong, New Zealand, New Caledonia, Argentina, Brazil, Chile, Costa Rica, Mexico, Uruguay, Venezuela. Domestic distribution includes hospitals, clinics,

    Quantity

    2678 devices