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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