BEUDAMED
    FDA Enforcement Class II Terminated

    Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 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-1986-2012 · Reported July 18, 2012

    Enforcement

    Recall Number
    Z-1986-2012
    Event ID
    62342
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Healthcare Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 18, 2012
    Initiation Date
    June 20, 2012
    Classification Date
    July 11, 2012
    Termination Date
    August 14, 2013
    Address
    3000 Minuteman Road, Andover, MA, 01810, United States

    Description

    Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 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

    Defibrillator/monitor cannot analyze an ECG report during acquisition of 12 lead ECG

    Code Info

    Serial Numbers: US00558452, US00558453, US00558493, US00558494, US00558539 US00558540, US00558546, US00558547, US00558569, US00558576 US00558584, US00558595, US00558596, US00558597, US00558615 US00558617, US00558618, US00558619, US00558620, US00558621 US00558625, US00558626, US00558627, US00558628, US00558629 US00558630, US00558640, US00558641, US00558642, US00558643 US00558644, US00558779, US00558780, US00558950, US00558952

    Distribution

    Worldwide Distribution - USA including FL, IN, MA, M, NY, OH, TN, TX, and VA. Internationally to AUSTRALIA, HONG KONG, and INDIA

    Quantity

    35 units