FDA-Device2012-07-18Class II
Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 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 Healthcare Inc.
Hazard
Defibrillator/monitor cannot analyze an ECG report during acquisition of 12 lead ECG
Sold states
Worldwide Distribution - USA including FL, IN, MA, M, NY, OH, TN, TX, and VA. Internationally to AUSTRALIA, HONG KONG, and INDIA
Affected count
35 units
Manufactured in
3000 Minuteman Road, Andover, MA, United States
Products
Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 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-1986-2012Don't want to check this manually?
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