FDA Device

Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator

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).

What You Should Do

Remedy

The Philips Urgent Medical Device Correction notification/ Field Safety Notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. The correction will consist of providing a hardware correction, free of charge, for all units affected by this issue.

Products

Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator
Brand
Philips Electronics North America Corporation
UPC
20 units - US00597060, US00597964, US00598048, US00598210, US00598784, US00599490, US00599495, US00599508, US00599572, US00599613, US00599615, US00599623, US00599726, US00600362, US00600363, US00600370, US00600422, US00600423, US00600438, US00600483

Units Affected

20 units ( 18 domestic, 2 foreign)