Philips Electronics North America Corporation recalls Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator
- Recall date
- September 28, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0278-2018
- FDA classification
- Class II
- Brand / firm
- Philips Electronics North America Corporation
- Sold / distributed
- 20 units affected. 18 domestic, 2 foreign.
Why it was recalled
Philips MRx devices have an EtCO2 module that may contain contamination; this contamination (will/may) cause the device to be unable to display the EtCO2 or CO2 waveform (capnogram).
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator
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