BEUDAMED
    FDA Recall Terminated

    Implantable Cardioverter Defibrilators Epic DR/HF (V-233/V-337/V-338), Epic Plus DR/VR/HF (V-236/V-239/V-196/V-239T/V-196T/V-350) Atlas DR (V242), and Atlas Plus DR/VR/HF (V-243/V-193C/V-340/V-341/V-343).

    Recall: Z-1017-05 · Initiated June 17, 2005

    Recall

    Recall Number
    Z-1017-05
    Event Number
    32465
    FEI Number
    2017865
    Product Code
    NIK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 17, 2005
    Posted
    July 19, 2005
    Terminated
    March 26, 2012
    Address
    St Jude Medical 15900 Valley View Ct, Sylmar, CA, 91342-3577

    Description

    Implantable Cardioverter Defibrilators Epic DR/HF (V-233/V-337/V-338), Epic Plus DR/VR/HF (V-236/V-239/V-196/V-239T/V-196T/V-350) Atlas DR (V242), and Atlas Plus DR/VR/HF (V-243/V-193C/V-340/V-341/V-343).

    Reason

    Two corrections to firmware due to Skipped-Charge Shock and Sensor Noise Anomaly are being made with one noninvasive upgrade.

    Action

    Recall was by letter to Physicians sent by FEDEX. Follow-up upgrade to programmers will be done by firm representatives to the new version 4.8.5.

    Distribution

    Nationwide and Sweden, Canada, Australia, New Zealand. South America and Asia

    Quantity

    30,000 domestically, 11,684 internationally