Ambulance Parameter Extension — Class II medical device recall Z-1342-2020
Terminated recall by Philips North America, LLC, reported 2020-03-04. M4758A Ambulance Parameter Extension (APE) kit may cause ECG "Leads Off" condition in hot, humid environments
| Recall number | Z-1342-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, LLC, Andover, MA, United States |
| Recall initiated | 2020-01-14 |
| Classified | 2020-02-21 |
| Reported by FDA | 2020-03-04 |
| Terminated | 2021-02-09 |
| Countries outside the US | AT, CH, DE, NL, NO, PL |
| Quantity | 43 units |
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.
Reason for recall
M4758A Ambulance Parameter Extension (APE) kit may cause ECG "Leads Off" condition in hot, humid environments
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1342-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.