Company: Philips Medical Systems, Inc.
Date of Enforcement Report:1/1/2014
Class lI:

PRODUCT

Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician. The HeartStart MRx EtCO2 Option monitors carbon dioxide (CO2) and measures end-tidal carbon dioxide (EtCO2). The option provides an EtCO2 value and a CO2 waveform on the devices display.Recall Number Z-0570-2014

REASON
MRx defibrillator displays a -?- for EtCO2 and does not display EtCO2 values when patient CO2 level falls below 7.6 mmHg

RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc., Andover, MA on 12/10/2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
18,529 units

DISTRIBUTION
Nationwide and Internationally

___________________________________