Recall Z-2842-2016— Philips Electronics North America Corporation

Name: FDA recall Z-2842-2016
Creator: U.S. Food and Drug Administration
Published: 2016-08-26

Class II · Terminated

Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2016-08-26, terminated 2020-07-24. It names 5 FDA 510(k) clearances: K062233, K061707, K051134 and 2 more. Product: HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A. Reason: The handle can separate from the MRx housing due to breakage of mounts on the rear case..

Recalling firm: Philips Electronics North America Corporation
Classification: Class II
Status: Terminated
Initiated: 2016-08-26
Terminated: 2020-07-24
Firm location: Andover, MA, United States

510(k) clearances named in this recall

5 on FDA's record

K062233 — HEARTSTART MRX MONITOR/DEFIBRILLATORPhilips Medical Systems North America, Inc.·cleared 2006-11-22
K061707 — HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONSPhilips Medical Systems·cleared 2006-08-11
K051134 — HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536APhilips Medical Systems·cleared 2005-09-08
K040404 — HEARTSTART MRX, MODEL M3535APhilips Medical Systems, Inc.·cleared 2004-05-04
K031187 — HEARTSTART MRX, MODEL M3535APhilips Medical Systems·cleared 2003-08-27

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

HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A

Reason for recall

The handle can separate from the MRx housing due to breakage of mounts on the rear case.

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