Company: Philips Medical Systems, Inc.
Date of Enforcement Report 3/19/2014
Class lI:
PRODUCT
Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with Q-CPR Meter Option B08 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-1194-2014
REASON
When the HeartStart MRx.is used with the Q-CPR Meter in defibrillation mode, the Q-CPR Meter may incorrectly display the Do Not Touch the Patient icon.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc., Andover, MA on 2/18/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
6583 units
DISTRIBUTION
Nationwide and Internationally
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