Philips Medical Systems, Inc. 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
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Philips Medical Systems, Inc.
Lot Codes / Batch Numbers
software revision J.30.58:
Products Sold
software revision J.30.58:
Philips Medical Systems, Inc. is recalling Philips Avalon Monitors with software revision J.30.58: Model Product FM20 M2702A ; FM30 M2 due to Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026