BEUDAMED
    FDA Recall 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 · Initiated June 20, 2012

    Recall

    Recall Number
    Z-1986-2012
    Event Number
    62342
    Firm
    Philips Healthcare Inc.
    FEI Number
    1218950
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 20, 2012
    Posted
    July 11, 2012
    Terminated
    August 14, 2013
    Address
    3000 Minuteman Road, Andover, MA, 01810

    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

    Action

    Philips Healthcare issued an Urgent Voluntary Medical Device Correction letter on June 20, 2012, to all affected customers. The Notification informs customers of the issue, identifies details (including models and software versions applicable) of units affected, instructions on actions to take while awaiting the correction, and identifies what action Philips plans to eliminate or remedy the issue A Philips Healthcare representative will contact customers to arrange for the updated R.03.03 software installation in all the affected devices. For questions customers were advised to call 1-800-722-9377. For questions regarding this recall call 978-687-1501.

    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