05
Mar
2014

Philips M3536A HeartStart MRx Cl II

0

Company: Philips Medical Systems, Inc.
Date of Enforcement Report:3/52014
Class lI:

PRODUCT

M3536A HeartStart MRx with Wireless Link Upgrade (861289) 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-1108-2014

REASON
Wireless Link may be unable to transmit data when configured for a specific data flow.

RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Andover, MA 2/18/2014. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
220 devices

DISTRIBUTION
Nationwide and Internationally

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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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