BEUDAMED
    FDA Enforcement Class II Terminated

    HeartStart MRx Monitor/Defibrillator The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.

    Recall: Z-1612-2016 · Reported May 11, 2016

    Enforcement

    Recall Number
    Z-1612-2016
    Event ID
    73825
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Electronics North America Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 11, 2016
    Initiation Date
    April 14, 2016
    Classification Date
    May 5, 2016
    Termination Date
    March 27, 2019
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032, United States

    Description

    HeartStart MRx Monitor/Defibrillator The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.

    Reason

    MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component.

    Code Info

    US00586611, US00589878, US00594232, US00588464, US00591080, US00594779, US00588657, US00592182, US00594913, US00589391, US00593861, US00595298, US00589472, US00594092, US00595443, US00589851, US00594168

    Distribution

    Worldwide Distribution - US including OH, CA, NC and Internationally to China, Iraq, Japan, and Korea.

    Quantity

    17