CLASS II Device recall · Reported 6 Jun 2018 · FDA Enforcement Report

HeartStart MRx Monitor/Defibrillator recalled

Philips Electronics North America is recalling HeartStart MRx Monitor/Defibrillator, distributed in North Carolina, Ohio. The recall was initiated on 3 May 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUS00588464, US00588657, US00589878, US00591080, US00593861

Quantity recalled5

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-2035-2018
FDA event ID: 79982
Recalling firm: Philips Electronics North America, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 3 May 2018
FDA classified: 30 May 2018
Reported: 6 Jun 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Pacemakers & Defibrillators

Timeline

3 May 2018	Recall initiated by company
30 May 2018	Classified by FDA	+27 days
6 Jun 2018	Published in enforcement report	+7 days

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

Reason for recall

The MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component. Failure to charge could potentially cause therapy to be interrupted or delayed.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automated external defibrillators (non-wearable) Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.

Where it was distributed

Worldwide Distribution to accounts in OH and NC. Foreign distribution to Lebanon.

North Carolina Ohio

Questions about this recall

Why was it recalled?

Which lots are affected?

US00588464, US00588657, US00589878, US00591080, US00593861

Where was it sold?

Worldwide Distribution to accounts in OH and NC. Foreign distribution to Lebanon.

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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19 Dec 2018Device	CLASS II	IntelliVue MX40 Patient Monitor recalled by Philips Electronics North	Philips Electronics North America	Device Malfunction	Nationwide
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3 Oct 2018Device	CLASS II	Allura Xper FD2O Biplane, System recalled by Philips Electronics North	Philips Electronics North America	Other	Nationwide
3 Oct 2018Device	CLASS II	AIIuraXperFDlO, System recalled by Philips Electronics North	Philips Electronics North America	Other	Nationwide

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