FDA-Device2016-05-11Class II
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.
Philips Electronics North America Corporation
Hazard
MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component.
Sold states
Worldwide Distribution - US including OH, CA, NC and Internationally to China, Iraq, Japan, and Korea.
Affected count
17
Manufactured in
3000 Minuteman Rd, Andover, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1612-2016Don't want to check this manually?
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