Z-1342-2020Class II

Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx...

Name: Z-1342-2020 Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx...
Creator: Philips North America, LLC
Published: 2020-01-14
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2020-01-14 / Terminated / root cause: manufacturing process

FDA source

Philips North America, LLC began a recall of Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx Monitor/Defibrillator - Product Usage: is intended to be used with... on 2020-01-14. FDA classified it as Class II and gives the reason as "M4758A Ambulance Parameter Extension (APE) kit may cause ECG "Leads Off" condition in hot, humid environments". 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-1342-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-14
Posted: 2020-02-21
Terminated: 2021-02-09
Recalling firm: Philips North America LLC
Product: 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.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: M4758A Ambulance Parameter Extension (APE) kit may cause ECG "Leads Off" condition in hot, humid environments
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Philips issued notification letter dated January 2020 to Philips Markets Organizations responsible for distributing the letters outside of the U.S Letter stated problem, health risk and is asking customers to follow the Action to be Taken by Customer/User section of the CIL: Philips recommends that the APE kit be removed from use and disposed of. Patients can of course be monitored and treated in ambulances using the MRx Monitor/Defibrillator without the APE kit. To acknowledge receipt of this notification, please complete and fax the Customer Reply Form back to Philips at your earliest convenience.
Quantity in commerce: 43 units
Distribution: International distribution in the countries of Austria, Germany, Netherlands, Norway, Poland, Switzerland
Product codes and lots: All

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1342-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1342-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-21

Product code MKJ

K063375Class IIIHeartstart Mrx, Models M3535a or M3536aPhilips Medical Systems / cleared 2007-01-11

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)