BEUDAMED
    FDA Enforcement Class II Terminated

    Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator

    Recall: Z-0278-2018 · Reported December 27, 2017

    Enforcement

    Recall Number
    Z-0278-2018
    Event ID
    78698
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Electronics North America Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    December 27, 2017
    Initiation Date
    September 28, 2017
    Classification Date
    December 21, 2017
    Termination Date
    October 12, 2018
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032, United States

    Description

    Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator

    Reason

    Philips MRx devices have an EtCO2 module that may contain contamination; this contamination (will/may) cause the device to be unable to display the EtCO2 or CO2 waveform (capnogram).

    Code Info

    20 units - US00597060, US00597964, US00598048, US00598210, US00598784, US00599490, US00599495, US00599508, US00599572, US00599613, US00599615, US00599623, US00599726, US00600362, US00600363, US00600370, US00600422, US00600423, US00600438, US00600483

    Distribution

    20 units affected. 18 domestic, 2 foreign.

    Quantity

    20 units ( 18 domestic, 2 foreign)