BEUDAMED
    FDA Recall Terminated

    Philips HeartStart MRx Monitor/Defibrillator Models: M3536A Options A20 - A27, HeartStart MRx ALS Monitor (Grey) 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-0593-2014 · Initiated June 7, 2013

    Recall

    Recall Number
    Z-0593-2014
    Event Number
    67052
    Firm
    Philips Medical Systems, Inc.
    FEI Number
    1218950
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    June 7, 2013
    Posted
    December 27, 2013
    Terminated
    March 22, 2017
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    Philips HeartStart MRx Monitor/Defibrillator Models: M3536A Options A20 - A27, HeartStart MRx ALS Monitor (Grey) 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

    Error in the printing of the therapy energy setting labels on Philips HeartStart M3536A MRx Monitor/Defibrillators. The first energy setting is labeled 10 when it should be labeled1-10

    Action

    Philips sent a Customer Information Letter dated June 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. During an EI of the firm, the firm had not reported the correction to FDA. The Customer Information letter informs the customers what the behavior is and under what circumstances. The correction consisted of a replacement label that was provided free of charge to all units affected by this issue. Philips Healthcare representatives have been contact customers with affected devices to arrange for installation of the replacement label. To correct this issue, Philips will replace the label free of charge. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the replacement label. This issue does not affect current product shipments. I f you need any further information or support concerning this issue, please contact your local Philips representative at 1-800-722-9377. Philips apologizes for any inconvenience caused by this problem.

    Distribution

    Worldwide Distribution - US Distribution including the states of IN, MS, TX and VA., and the countries of DENMARK, FRANCE, GERMANY, SPAIN and SWITZERLAND.

    Quantity

    93 units