Home / Recalls / Philips Electronics North America Corporation / Z-0278-2018

Z-0278-2018 Class II Terminated

Recalled by Philips Electronics North America Corporation — Andover, MA

Recall Details

Product Type
Devices
Report Date
December 27, 2017
Initiation Date
September 28, 2017
Termination Date
October 12, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
20 units ( 18 domestic, 2 foreign)

Product Description

Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator

Reason for Recall

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).

Distribution Pattern

20 units affected. 18 domestic, 2 foreign.

Code Information

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

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