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.
FDA Recall Z-1342-2020 · Posted None
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Recalling FirmPhilips North America, LLC
Recall StatusTerminated
Product CodeMKJ
Date Initiated2020-01-14
Date Terminated2021-02-09
Product Quantity43 units
Reason for Recall
M4758A Ambulance Parameter Extension (APE) kit may cause ECG "Leads Off" condition in hot, humid environments
Firm 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.
Root Cause
Process design
Distribution Pattern
International distribution in the countries of Austria, Germany, Netherlands, Norway, Poland, Switzerland
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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