Philips Electronics North America Corporation recalls HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automated external defibrillat…

Recall date

May 3, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2035-2018

FDA classification

Class II

Brand / firm

Philips Electronics North America Corporation

Sold / distributed

Worldwide Distribution to accounts in OH and NC. Foreign distribution to Lebanon.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.