Company:Philips Electronics North America Corporation.
Date of Enforcement Report 12/2/2015
Class lI:
PRODUCT
Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. For use for the termination of ventricular tachycardia and ventricular fibrillation.
Recall Number Z-0320-2016
REASON
The following MRx software issue has been identified: MRx model M3535A with software version F.03.06 and earlier, and model M3536A with version T.00.05 and earlier may stop the automated Ready-For-Use (RFU) test in an abnormal state when the device is turned off.
RECALLING FIRM/MANUFACTURER
Philips Electronics North America Corporation. on 10/14/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
81,161
DISTRIBUTION
Nationwide and Internationally
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