Company:Philips Healthcare Inc.
Date of Enforcement Report 7/18/12
Class ll:
PRODUCT
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. Z-1986-2012
REASON
Defibrillator/monitor cannot analyze an ECG report during acquisition of 12 lead ECG
RECALLING FIRM/MANUFACTURER
Philips Healthcare Inc., Andover, MA on 6/20/2012. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
35 units
DISTRIBUTION
Nationwide and Internationally
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