Philips HeartStart MRx Defibrillators Recalled for EtCO2 Module Contamination
Philips is recalling 20 HeartStart MRx defibrillators because EtCO2 module contamination may prevent the device from displaying the CO2 waveform.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a functional defect (inability to display a waveform) with no reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Philips Electronics North America Corporation is recalling 20 units of the HeartStart MRx Monitor/Defibrillator. The recall involves 18 domestic units and 2 foreign units.
The recall is due to potential contamination in the EtCO2 module. This contamination may cause the device to be unable to display the EtCO2 or CO2 waveform (capnogram). The source text does not report any illnesses, injuries, or deaths associated with this defect.
Affected units are identified by specific serial codes, including US00597060, US00597964, and US00598048. The source text does not provide specific instructions for consumers on how to return the devices or contact the manufacturer.
The recalled product
- Product
- Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator
- Manufacturer
- Philips Electronics North America Corporation
- Category
- Medical Device — Defibrillator
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 (20)
- 20 units - US00597060
- US00597964
- US00598048
- US00598210
- US00598784
- US00599490
- US00599495
- US00599508
- US00599572
- US00599613
- US00599615
- US00599623
- US00599726
- US00600362
- US00600363
- US00600370
- US00600422
- US00600423
- US00600438
- US00600483
Distribution
Distribution scope not specified by the agency.
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