Recall Z-0219-2016— Philips Medical Systems, Inc.

Name: FDA recall Z-0219-2016
Creator: U.S. Food and Drug Administration
Published: 2014-12-23

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems, Inc., initiated 2014-12-23, terminated 2020-09-09. It names 6 FDA 510(k) clearances: K063375, K062233, K061707 and 3 more. Product: HeartStart MRx monitor/defibrillator Models M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician. Reason: MRx monitor/defibrillator could reboot at an indeterminate time, potentially causing therapy to be interrupted or delayed.

Recalling firm: Philips Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-12-23
Terminated: 2020-09-09
Firm location: Andover, MA, United States

510(k) clearances named in this recall

6 on FDA's record

K063375 — HEARTSTART MRX, MODELS M3535A OR M3536APhilips Medical Systems·cleared 2007-01-11
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, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician

Reason for recall

MRx monitor/defibrillator could reboot at an indeterminate time, potentially causing therapy to be interrupted or delayed

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