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Philips Medical Systems, Inc. recalls M3536A HeartStart MRx with Wireless Link Upgrade (861289) The HeartStart MRx is for use for the termination of ventri
Recalled March 5, 2014 · FDA recall Z-1108-2014 · Philips Medical Systems
Hazard
Wireless Link may be unable to transmit data when configured for a specific data flow. · FDA Class II
Units
220 devices
Sold at
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.
Description
Wireless Link may be unable to transmit data when configured for a specific data flow.
Product
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.
Manufacturer(s)
Philips Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →