CLASS II Device recall · Reported 27 Dec 2017 · FDA Enforcement Report

Automated External Defibrillator recalled by Philips Electronics North

Philips Electronics North America is recalling Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator. The recall was initiated on 28 Sep 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes20 units - US00597060, US00597964, US00598048, US00598210, US00598784, US00599490, US00599495, US00599508, US00599572, US00599613, US00599615, US00599623, US00599726, US00600362, US00600363, US00600370, US00600422, US00600423, US00600438, US00600483

Quantity recalled20 units ( 18 domestic, 2 foreign)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0278-2018
FDA event ID: 78698
Recalling firm: Philips Electronics North America, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 28 Sep 2017
FDA classified: 21 Dec 2017
Reported: 27 Dec 2017
Type: Voluntary: Firm initiated
Reason category: Other Reasons
Device type: Pacemakers & Defibrillators

Timeline

28 Sep 2017	Recall initiated by company
21 Dec 2017	Classified by FDA	+84 days
27 Dec 2017	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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).

Product as listed by the FDA

Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator

Where it was distributed

20 units affected. 18 domestic, 2 foreign.

Questions about this recall

Why was it 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).

Which lots are affected?

20 units - US00597060, US00597964, US00598048, US00598210, US00598784, US00599490, US00599495, US00599508, US00599572, US00599613, US00599615, US00599623, US00599726, US00600362, US00600363, US00600370, US00600422, US00600423, US00600438, US00600483

Where was it sold?

20 units affected. 18 domestic, 2 foreign.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Philips Electronics North America

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