Philips HeartStart MRx Defibrillator Recall for EtCO2 Display Error
Philips is recalling HeartStart MRx defibrillators because they display a question mark instead of a value when patient CO2 levels fall below 7.6 mmHg.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a monitoring failure in a critical care device, which fits the rubric criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips Medical Systems, Inc. is recalling 18,529 units of the HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement. The recall affects devices running software versions F.02, R.02, 9.xx, or any earlier versions. The specific defect involves the EtCO2 option, which displays a question mark (-?-) and fails to display end-tidal carbon dioxide (EtCO2) values when the patient's CO2 level falls below 7.6 mmHg.
The affected devices are distributed in the US Nationwide and overseas. The HeartStart MRx is intended for use by qualified medical personnel trained in basic life support, advanced cardiac support, or defibrillation, and must be used by or on the order of a physician. The EtCO2 option monitors carbon dioxide and provides an EtCO2 value and waveform on the device display.
Healthcare facilities should contact Philips Medical Systems for instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating that use of the product could, in some cases, cause temporary or medically reversible adverse health consequences.
The recalled product
- 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 q
- Manufacturer
- Philips Medical Systems, Inc.
- Affected units
- 18,529
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Software versions: F.02
- R.02
- 9.xx or any earlier versions Addendum Models: M3532A
- M3535A
- M3536AM
- M3536MC
- M3536M2
- M3536M4
- M3536M5
Distribution
Distributed nationwide across the United States.
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