Recall Z-1342-2020— Philips North America, LLC

Name: FDA recall Z-1342-2020
Creator: U.S. Food and Drug Administration
Published: 2020-01-14

Class II · Terminated

Class II FDA medical device recall by Philips North America, LLC, initiated 2020-01-14, terminated 2021-02-09. It names one FDA 510(k) clearance: K063375. 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.

Recalling firm: Philips North America, LLC
Classification: Class II
Status: Terminated
Initiated: 2020-01-14
Terminated: 2021-02-09
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K063375 — HEARTSTART MRX, MODELS M3535A OR M3536APhilips Medical Systems·cleared 2007-01-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.