BEUDAMED
    FDA Recall Terminated

    Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter

    Recall: Z-0949-2015 · Initiated December 18, 2014

    Recall

    Recall Number
    Z-0949-2015
    Event Number
    70066
    Firm
    St Jude Medical Cardiac Rhythm Management Division
    FEI Number
    2017865
    Product Code
    NVZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 18, 2014
    Posted
    January 9, 2015
    Terminated
    March 30, 2016
    Address
    15900 Valley View Ct, Sylmar, CA, 91342-3577

    Description

    Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter

    Reason

    Transmitter may initiate a software reset resulting in backup operation in some implanted St. Jude Medical Radio Frequency (RF) enabled Implantable Cardioverter Assura, Unify Assura, and Quadra Assura ICDs and Assurity and Allure Pacemakers.

    Action

    The firm, St. Jude Medical, sent an "Important Medical Device Correction" Dear Doctor Letter dated 12/18/14 to customers to inform them that the Merlin@home transmitters may initiate a software reset resulting in backup operation in some implanted St. Jude Medical Radio Frequency (RF) enabled Implantable Cardioverter Defibrillators (ICDs) and Pacemakers. The letter informs the customers of the problems identified and the actions to be taken. Customers with questions or concerns are instructed to contact their local St. Jude Medical representative or St. Jude Medical's Technical Services Department at 1-800-722-3774.

    Distribution

    Worldwide Distribution: US (nationwide) and countries of: EU, Mideast, Canada, Australia/New Zealand, and Asia-Pacific (including Japan).

    Quantity

    257,456 units