FDA Device recall Z-0278-2018
Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator
- FDA Device
- Class II
- terminated
- Published 2017-12-27
On 2017-12-27 the FDA classified a Class II recall of Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator by Philips Electronics North America, citing 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 (capnogra….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0278-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-09-28 |
| Published | 2017-12-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Electronics North America |
| Distribution | n/a |
Product
Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator
Reason
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).
Identifiers
| code_info | 20 units - US00597060, US00597964, US00598048, US00598210, US00598784, US00599490, US00599495, US00599508, US00599572,…20 units - US00597060, US00597964, US00598048, US00598210, US00598784, US00599490, US00599495, US00599508, US00599572, US00599613, US00599615, US00599623, US00599726, US00600362, US00600363, US00600370, US00600422, US00600423, US00600438, US00600483 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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All Philips Electronics North America recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0278-2018%22
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