Recall Z-0320-2016— Philips Electronics North America Corporation

Name: FDA recall Z-0320-2016
Creator: U.S. Food and Drug Administration
Published: 2015-10-14

Class II · Terminated

Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2015-10-14, terminated 2018-09-13. It names 5 FDA 510(k) clearances: K062233, K061707, K051134 and 2 more. Product: Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. For use for the termination of ventricular tachycardia and ventricular fibrillation.. Reason: The following MRx software issue has been identified: MRx model M3535A with software version F.03.06 and earlier, and model M3536A with version T.00.05 and earlier may stop the automated Ready-For-Use (RFU) test in an abnormal state when the device is turned off..

Recalling firm: Philips Electronics North America Corporation
Classification: Class II
Status: Terminated
Initiated: 2015-10-14
Terminated: 2018-09-13
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

Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. For use for the termination of ventricular tachycardia and ventricular fibrillation.

Reason for recall

The following MRx software issue has been identified: MRx model M3535A with software version F.03.06 and earlier, and model M3536A with version T.00.05 and earlier may stop the automated Ready-For-Use (RFU) test in an abnormal state when the device is turned off.

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