CLASS II Device recall · Reported 4 Mar 2020 · FDA Enforcement Report

Ambulance Parameter Extension (APE) kit M4758A recalled

Philips North America is recalling Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart, distributed nationwide in the US. The recall was initiated on 14 Jan 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll

Quantity recalled43 units

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-1342-2020
FDA event ID: 84796
Recalling firm: Philips North America, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 14 Jan 2020
FDA classified: 21 Feb 2020
Reported: 4 Mar 2020
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Pacemakers & Defibrillators

Timeline

14 Jan 2020	Recall initiated by company
21 Feb 2020	Classified by FDA	+38 days
4 Mar 2020	Published in enforcement report	+12 days

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

Reason for recall

M4758A Ambulance Parameter Extension (APE) kit may cause ECG "Leads Off" condition in hot, humid environments

Product as listed by the FDA

Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx Monitor/Defibrillator - Product Usage: is intended to be used with the M3536A MRx in EMS environments.

Where it was distributed

International distribution in the countries of Austria, Germany, Netherlands, Norway, Poland, Switzerland

Nationwide

Questions about this recall

Is Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart recalled?

Yes. Philips North America recalled Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart on 14 Jan 2020. The recall is Class II and its status is Terminated. Recall number Z-1342-2020.

Why was it recalled?

M4758A Ambulance Parameter Extension (APE) kit may cause ECG "Leads Off" condition in hot, humid environments

Which lots are affected?

All

Where was it sold?

International distribution in the countries of Austria, Germany, Netherlands, Norway, Poland, Switzerland

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

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