Dec

2015

HeartStart MRx Monitor/Defibrillator Cl II

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

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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HeartStart MRx Monitor/Defibrillator Cl II

Amy Sellers

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