Oct

2014

Cl II Philips Avalon Monitors

Company: Philips Medical Systems, Inc.
Date of Enforcement Report 10/29/2014
Class lI:

PRODUCT

Philips Avalon Monitors with software revision J.30.58: Model Product FM20 M2702A ; FM30 M2703A ; FM50 M2705A Intended for: ” Monitoring the physiological parameters of pregnant women ” Non-invasive monitoring of fetal heart rates and movements. Recall Number Z-0105-2015

REASON
Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped

RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc ,Andover, MA on 10/3/2014. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
118 units

DISTRIBUTION
Nationwide and Internationally

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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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Cl II Philips Avalon Monitors

Amy Sellers

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