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Recall Observatory FDA recall evidence

Device product

HeartStart MRx Monitor/Defibrillator 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.

Z-1612-2016

April 14, 2016

Class II

Product summary

Firm
Philips Electronics North America Corporation
Event
Event 73825
Status
Terminated
Classification
Class II
Quantity
17
Official record key
device-enforcement:Z-1612-2016

Official wording

Reason: MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component.

Code information: US00586611, US00589878, US00594232, US00588464, US00591080, US00594779, US00588657, US00592182, US00594913, US00589391, US00593861, US00595298, US00589472, US00594092, US00595443, US00589851, US00594168

Distribution pattern: Worldwide Distribution - US including OH, CA, NC and Internationally to China, Iraq, Japan, and Korea.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component.