Company: Philips Medical Systems, Inc.
Date of Enforcement Report:3/52014
Class lI:
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.
Recall Number Z-1108-2014
REASON
Wireless Link may be unable to transmit data when configured for a specific data flow.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Andover, MA 2/18/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
220 devices
DISTRIBUTION
Nationwide and Internationally
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