11
Nov
2015

HeartStart MRx monitor/defibrillator Cl II

0

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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About the author

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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