Philips North America, LLC recalls Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx Monitor/Defibrillator - Prod…

Recall date

January 14, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1342-2020

FDA classification

Class II

Brand / firm

Philips North America, LLC

Sold / distributed

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

Why it was recalled

M4758A Ambulance Parameter Extension (APE) kit may cause ECG "Leads Off" condition in hot, humid environments

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.