BEUDAMED
    FDA Recall Terminated

    Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or Higher, automated external defibrillator.

    Recall: Z-1311-2014 · Initiated March 5, 2014

    Recall

    Recall Number
    Z-1311-2014
    Event Number
    67749
    Firm
    ZOLL Medical Corporation
    FEI Number
    1220908
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 5, 2014
    Posted
    March 31, 2014
    Terminated
    January 29, 2021
    Address
    269 Mill Road, Chelmsford, MA, 01824

    Description

    Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or Higher, automated external defibrillator.

    Reason

    Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used

    Action

    Zoll Medical issued a Notification letter daetd March 5, 2014, to all affected consignees. The notification letter provides information on how to avoid the issue and instructs customers to contact ZOLL to get affected devices updated. Customers will be given the option to have a software upgrade kit sent to them to update their devices or return devices to ZOLL Service department in Chelmsford Massachusetts to have the device upgraded with the latest software release (Software version 02.16.04.00). Customers with questions were instructed to contact the 24/7 technical support numbers 1 (800) 348 9011 or +1 (978) 421 9460 to assist users with any aspect of this notice.

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Canada, AE, Afganistian, Australia, Belgium, Czech Republic , China, Chile, Croatia, Denmark, France, Great Britain, Hungary, Israel, Italy, Japan, Korea, Kuwait, Russia, Saudi Arabia, Singapore, South Africa,Thailand, and Turkey.

    Quantity

    3,169 units