Recall Z-2035-2018— Philips Electronics North America Corporation

Name: FDA recall Z-2035-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-03

Class II · Terminated

Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2018-05-03, terminated 2019-10-17. It names one FDA 510(k) clearance: K063375. Product: HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automated external defibrillators (non-wearable) 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: The MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component. Failure to charge could potentially cause therapy to be interrupted or delayed..

Recalling firm: Philips Electronics North America Corporation
Classification: Class II
Status: Terminated
Initiated: 2018-05-03
Terminated: 2019-10-17
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

HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automated external defibrillators (non-wearable) 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

The MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component. Failure to charge could potentially cause therapy to be interrupted or delayed.

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