FDA Device recall Z-1342-2020
Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx Monitor/Defibrillator - Product Usage: is intend…
- FDA Device
- Class II
- terminated
- Published 2020-03-04
On 2020-03-04 the FDA classified a Class II recall of Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx Monitor/Defibrillator - Product Usage: is intend… by Philips North America, citing M4758A Ambulance Parameter Extension (APE) kit may cause ECG "Leads Off" condition in hot, humid environments.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1342-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-14 |
| Published | 2020-03-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Philips North America |
| Distribution | n/a |
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
M4758A Ambulance Parameter Extension (APE) kit may cause ECG "Leads Off" condition in hot, humid environments
Identifiers
| code_info | All |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1342-2020%22
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