Philips Avalon Fetal Monitors Recalled for Software Measurement Error
Philips is recalling Avalon fetal monitors with specific software because automatic blood pressure measurements stop in certain modes.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device used for monitoring high-risk patients (pregnant women) where a failure to measure blood pressure could lead to undetected health issues, fitting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips Medical Systems, Inc. is recalling 118 units of Philips Avalon Monitors (models FM20, FM30, and FM50) equipped with software revision J.30.58. These devices are intended for the non-invasive monitoring of fetal heart rates and movements, as well as the physiological parameters of pregnant women.
The recall is due to a software defect where, when the monitors are in time-synchronized automatic or sequence mode, the non-invasive blood pressure (NBP) automatic measurement series is stopped. This issue affects the device's ability to continuously monitor blood pressure in specific operational modes.
The affected units were distributed worldwide, including the United States and numerous international markets. Users of these devices should contact Philips Medical Systems for instructions on how to resolve the software issue.
The recalled product
- 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.
- Manufacturer
- Philips Medical Systems, Inc.
- Category
- Medical Device — Fetal Monitor
- Affected units
- 118
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- software revision J.30.58:
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Philips Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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