Philips North America, LLC 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Philips North America, LLC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
All
Philips North America, LLC is recalling Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx Monitor/D due to M4758A Ambulance Parameter Extension (APE) kit may cause ECG "Leads Off" condition in hot, humid environments. Based on FDA medical device recall database.
Summary derived from FDA notice
The following details were not provided by the FDA: specific lot/serial numbers.
Reason for Recall
As stated by FDA
M4758A Ambulance Parameter Extension (APE) kit may cause ECG "Leads Off" condition in hot, humid environments
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026