medical Class II Updated 2018-06-06

Philips Electronics North America Corporation recalls HeartStart MRx Monitor/Defibrillator, Model No. M3535A (8612

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Affected States: OH, NC
Lot/Code Info: US00588464, US00588657, US00589878, US00591080, US00593861
View official government recall

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