BEUDAMED
    FDA Enforcement Class II 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 · Reported April 9, 2014

    Enforcement

    Recall Number
    Z-1311-2014
    Event ID
    67749
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ZOLL Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 9, 2014
    Initiation Date
    March 5, 2014
    Classification Date
    March 31, 2014
    Termination Date
    January 29, 2021
    Address
    269 Mill Road, N/A, Chelmsford, MA, 01824, United States

    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

    Code Info

    System Software Version 02.10.02.00 or Higher

    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