Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement The HeartStart MRx is...
FDA Recall #Z-0570-2014 — Class II — December 10, 2013
Product Description
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.
Reason for Recall
MRx defibrillator displays a -?- for EtCO2 and does not display EtCO2 values when patient CO2 level falls below 7.6 mmHg
Recalling Firm
Philips Medical Systems, Inc. — Andover, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
18,529 units
Distribution
US Nationwide and OUS.
Code Information
Software versions: F.02, R.02, 9.xx or any earlier versions Addendum Models: M3532A, M3535A, M3536AM, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 M3535A- HeartStart MRx Defibrillator Monitor M3536A- HeartStart MRx Defibrillator Monitor EtC02 Options A04 A05 A06 All M3532A Upgrade
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated