Home / Recalls / Medical Devices
Philips Electronics North America Corporation recalls Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator
Recalled December 27, 2017 · FDA recall Z-0278-2018 · Philips Electronics North America
Hazard
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). · FDA Class II
Units
20 units ( 18 domestic, 2 foreign)
Sold at
20 units affected. 18 domestic, 2 foreign.
Description
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).
Product
Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator
Manufacturer(s)
Philips Electronics North America Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →