FDA-Device2026-07-01Class IIPROCESSING DEFECT
Philips Avalon FM20 Fetal Monitor recalled for speaker connector assembly defect
What this means
Certain Philips Avalon FM20 Fetal Monitors have a speaker connector that was assembled incorrectly. This defect can cause cables to pull out of the device housing, which may result in loss of speaker output—either intermittently or permanently. This affects audio alerts that are critical to clinical monitoring.
- If you operate or maintain one of the affected monitors (check the serial number list), contact Philips North America for inspection and repair.
- Do not remove or force reconnect cables if you notice looseness; contact Philips instead.
- Continue using the monitor for now, but ensure backup audio or visual alert systems are in place until the device is serviced.
The agency's original wording
Hazard
Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and The countries of AE, AT, AU, BE, BG, BH, BR, CA, CH, CN, CR, CZ, DE, ES, FI, FR, GB, GR, HK, ID, IL, IN, IT, JO, JP, KR, KR, LT, LU, LV, MX, MY, NL, NZ, OM, SA, SE, SG, SI, TR, TW, ZA.
Affected count
285 units
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2522-2026More Philips recalls
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