Recall Z-0489-2018— Philips North America, LLC

Name: FDA recall Z-0489-2018
Creator: U.S. Food and Drug Administration
Published: 2017-07-12

Class I · Terminated

Class I FDA medical device recall by Philips North America, LLC, initiated 2017-07-12, terminated 2020-05-27. It names 5 FDA 510(k) clearances: K062233, K061707, K051134 and 2 more. Product: MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 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: Affected units may have a defective component that is intended to protect the internal circuitry from high voltages during shock delivery. The defective component may also prevent delivery of shocks in AED mode..

Recalling firm: Philips North America, LLC
Classification: Class I
Status: Terminated
Initiated: 2017-07-12
Terminated: 2020-05-27
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

MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 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

Affected units may have a defective component that is intended to protect the internal circuitry from high voltages during shock delivery. The defective component may also prevent delivery of shocks in AED mode.

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