FDA recall Z-0278-2018

Philips Electronics North America Corporation · Class II · device

Product

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

20 units affected. 18 domestic, 2 foreign.

Key facts

Status: Terminated
Initiation date: 2017-09-28
Report date: 2017-12-27
Termination date: 2018-10-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0278-2018