FDA-Device2017-12-27Class II
Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator
Philips Electronics North America Corporation
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).
Sold states
20 units affected. 18 domestic, 2 foreign.
Affected count
20 units ( 18 domestic, 2 foreign)
Manufactured in
3000 Minuteman Rd, Andover, MA, United States
Products
Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0278-2018Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief