Automated External Defibrillator — Class II medical device recall Z-0278-2018
Terminated recall by Philips Electronics North America Corporation, reported 2017-12-27. Philips MRx devices have an EtCO2 module that may contain contamination; this contamination (will/may) cause t
| Recall number | Z-0278-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Electronics North America Corporation, Andover, MA, United States |
| Recall initiated | 2017-09-28 |
| Classified | 2017-12-21 |
| Reported by FDA | 2017-12-27 |
| Terminated | 2018-10-12 |
Product
Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator
Reason for recall
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0278-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.