BEUDAMED
    FDA Recall Terminated

    HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A

    Recall: Z-2842-2016 · Initiated August 26, 2016

    Recall

    Recall Number
    Z-2842-2016
    Event Number
    75041
    Firm
    Philips Electronics North America Corporation
    FEI Number
    1218950
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 26, 2016
    Terminated
    July 24, 2020
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A

    Reason

    The handle can separate from the MRx housing due to breakage of mounts on the rear case.

    Action

    Philips Healthcare issued customer an Urgent Medical Device Correction notification/Field Safety Notice on 11/19/14. The Urgent Medical Device Correction notification/Field Safety Notice FSN86100158A 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. You can continue to use your MRx prior to receiving the hardware upgrade. If one or both sides of the handle are found to have separated from the MRx housing, continue to treat your patient per existing protocols. Do not use the handle to carry the MRx. The MRx can be carried in another manner. For example, the MRx shoulder strap or bed rail hook can be used if available on the unit A hardware upgrade will be provided free of charge for all units affected by one or more of these issues. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the upgrade. Contact your local Philips representative or call 1-800-722-9377.

    Distribution

    Worldwide distribution. US Nationwide, Canada, AUSTRALIA, FRANCE, GERMANY, INDIA, JAPAN, NETHERLANDS, SOUTH AFRICA, SPAIN, SWEDEN, THAILAND, and UNITED KINGDOM.

    Quantity

    394 units