# FDA recall Z-1342-2020

> **Philips North  America, LLC** · Class II · device recall initiated 2020-01-14.

## 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

## Distribution

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

## Key facts

- **Recall number:** Z-1342-2020
- **Recalling firm:** Philips North  America, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-14
- **Report date:** 2020-03-04
- **Termination date:** 2021-02-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1342-2020

## Citation

> AI Analytics. FDA recall Z-1342-2020. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/Z-1342-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*