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Recall Observatory FDA recall evidence

Device product

Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator

Z-0278-2018

September 28, 2017

Class II

Product summary

Firm
Philips Electronics North America Corporation
Event
Event 78698
Status
Terminated
Classification
Class II
Quantity
20 units ( 18 domestic, 2 foreign)
Official record key
device-enforcement:Z-0278-2018

Official wording

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

Distribution pattern: 20 units affected. 18 domestic, 2 foreign.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).