FDA recall Z-1342-2020

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

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

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