FDA-Device2015-01-21Class II
HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 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.
Philips Medical Systems, Inc.
Hazard
Device may malfunction, which could cause therapy to be delayed, disabled, or delivered inadvertently.
Sold states
Worldwide Distribution - US Nationwide
Affected count
74,499 devices
Manufactured in
3000 Minuteman Rd, Andover, MA, United States
Products
HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 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-0963-2015Don't want to check this manually?
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