BEUDAMED
    FDA Enforcement Class II Terminated

    M3536A HeartStart MRx with Wireless Link Upgrade (861289) 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-1108-2014 · Reported March 5, 2014

    Enforcement

    Recall Number
    Z-1108-2014
    Event ID
    67481
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 5, 2014
    Initiation Date
    February 18, 2014
    Classification Date
    February 26, 2014
    Termination Date
    November 12, 2015
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032, United States

    Description

    M3536A HeartStart MRx with Wireless Link Upgrade (861289) 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

    Wireless Link may be unable to transmit data when configured for a specific data flow.

    Code Info

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    Distribution

    Worldwide Distribution - USA including AZ, CA, FL, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NY, OH, OK, OR, PA, SC, TN, TX,and VA and Internationally to Australia, Norway, and Spain.

    Quantity

    220 devices