FDA-Device2014-03-05Class II
M3536A HeartStart MRx with Wireless Link Upgrade (861289) 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
Wireless Link may be unable to transmit data when configured for a specific data flow.
Sold states
Worldwide Distribution - USA including AZ, CA, FL, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NY, OH, OK, OR, PA, SC, TN, TX,and VA and Internationally to Australia, Norway, and Spain.
Affected count
220 devices
Manufactured in
3000 Minuteman Rd, Andover, MA, United States
Products
M3536A HeartStart MRx with Wireless Link Upgrade (861289) 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-1108-2014Don't want to check this manually?
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