Z-0278-2018Class II

Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator

Name: Z-0278-2018 Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator
Creator: Philips Electronics North America Corporation
Published: 2017-09-28
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2017-09-28 / Terminated / root cause: manufacturing process

FDA source

Philips Electronics North America Corporation began a recall of Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator on 2017-09-28. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0278-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-28
Posted: 2017-12-21
Terminated: 2018-10-12
Recalling firm: Philips North America LLC
Product: Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator
Product code: MSX System, Network And Communication, Physiological Monitors
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).
Root cause tag: manufacturing process
FDA 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 in commerce: 20 units ( 18 domestic, 2 foreign)
Distribution: 20 units affected. 18 domestic, 2 foreign.
Product codes and lots: 20 units - US00597060, US00597964, US00598048, US00598210, US00598784, US00599490, US00599495, US00599508, US00599572, US00599613, US00599615, US00599623, US00599726, US00600362, US00600363, US00600370, US00600422, US00600423, US00600438, US00600483

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0278-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0278-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-27	2017-12-21

Product code MSX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)