BEUDAMED
    FDA Enforcement Class II Terminated

    HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, and M3536M9.

    Recall: Z-1499-2020 · Reported March 25, 2020

    Enforcement

    Recall Number
    Z-1499-2020
    Event ID
    84841
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips North America, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 25, 2020
    Initiation Date
    February 26, 2020
    Classification Date
    March 13, 2020
    Termination Date
    December 8, 2022
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032, United States

    Description

    HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, and M3536M9.

    Reason

    Philips has received a number of reports of HeartStart MRx Monitor/Defibrillators that have suffered internal damage and were not able to deliver therapy after having been dropped or subjected to a severe mechanical shock, even though the device did not have visible external damage or the Ready for Use ( RFU ) indicator on the unit did not immediately indicate a problem. One of these reports involved a death of a patient who could not be resuscitated.

    Code Info

    All units are affected by this recall

    Distribution

    US Nationwide domestic distribution. Worldwide foreign distribution.

    Quantity

    97788 units