BEUDAMED
    FDA Recall 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 · Initiated February 18, 2014

    Recall

    Recall Number
    Z-1108-2014
    Event Number
    67481
    Firm
    Philips Medical Systems, Inc.
    FEI Number
    1218950
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 18, 2014
    Posted
    February 26, 2014
    Terminated
    November 12, 2015
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    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.

    Action

    Philips Healthcare sent an Urgent Medical Device Correction letter to all consignees on February 18, 2014. The Letter informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. Philips is initiating a correction to affected devices. Philips will release a new version of Wireless Link software V2.0.0.3 sub1 that corrects the issue. The correction will be provided free of charge to all units affected by this issue. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the software upgrade. Customers with questons were instructed to call 1-800-722-9377. For questions regarding this recall call 800-722-9377.

    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