FDA Medical Device Recalls (openFDA)
Philips Electronics North America Corporation: Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator
- Recall number
- Z-0278-2018
- Recalling firm
- Philips Electronics North America Corporation
- Product
- Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator
- Status
- Terminated
- Initiated
- 2017-09-28
- Posted
- not on file
- Terminated
- 2018-10-12
- 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).
- Root cause
- Nonconforming Material/Component
- Action
- The Philips Urgent Medical Device Correction notification/ Field Safety Notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. The correction will consist of providing a hardware correction, free of charge, for all units affected by this issue.
- Quantity
- 20 units ( 18 domestic, 2 foreign)
- Distribution
- 20 units affected. 18 domestic, 2 foreign.
- Lot, serial or model codes
- 20 units - US00597060, US00597964, US00598048, US00598210, US00598784, US00599490, US00599495, US00599508, US00599572, US00599613, US00599615, US00599623, US00599726, US00600362, US00600363, US00600370, US00600422, US00600423, US00600438, US00600483
- 510(k) numbers
- ["K031187","K040404","K051134","K061707","K062233","K063375"]
- PMA numbers
- not on file
- Product code
- MSX
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28