Company: Philips Medical Systems, Inc.
Date of Enforcement Report 11/11/2015
Class lI:
PRODUCT
HeartStart MRx monitor/defibrillator Models 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
Recall Number Z-0219-2016
REASON
MRx monitor/defibrillator could reboot at an indeterminate time, potentially causing therapy to be interrupted or delayed.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc., Andover, MA on 12/23/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
75,693 units
DISTRIBUTION
Worldwide
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