FDA-Device2018-06-06Class II
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 physici
Philips Electronics North America Corporation
Hazard
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.
Sold states
Worldwide Distribution to accounts in OH and NC. Foreign distribution to Lebanon.
Affected count
5
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2035-2018Don't want to check this manually?
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