Reported Jan 1, 2014 · Terminated
Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement The HeartStart MRx is for use for the…
Philips Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Medical Systems, Inc. · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
- 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.
- Lot codes and dates
- Software versions
F.02R.029.xx
- or any earlier versions Addendum ModelsM3532A, 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
- Software versions
- Amount recalled
- 18,529 units
Where it was sold
- Nationwide
Why it was recalled
MRx defibrillator displays a -?- for EtCO2 and does not display EtCO2 values when patient CO2 level falls below 7.6 mmHg
This product could cause temporary or reversible health problems — stop using it.
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