BEUDAMED
    FDA Enforcement Class II Terminated

    Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx Monitor/Defibrillator - Product Usage: is intended to be used with the M3536A MRx in EMS environments.

    Recall: Z-1342-2020 · Reported March 4, 2020

    Enforcement

    Recall Number
    Z-1342-2020
    Event ID
    84796
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips North America, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 4, 2020
    Initiation Date
    January 14, 2020
    Classification Date
    February 21, 2020
    Termination Date
    February 9, 2021
    Address
    3000 Minuteman Rd, N/A, Andover, MA, 01810-1032, United States

    Description

    Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx Monitor/Defibrillator - Product Usage: is intended to be used with the M3536A MRx in EMS environments.

    Reason

    M4758A Ambulance Parameter Extension (APE) kit may cause ECG "Leads Off" condition in hot, humid environments

    Code Info

    All

    Distribution

    International distribution in the countries of Austria, Germany, Netherlands, Norway, Poland, Switzerland

    Quantity

    43 units