Philips North America Llc: System, Monitoring, Perinatal
Recall Summary Philips is recalling the Avalon Fetal Monitor (model FM 30, part number M2703A) due to incorrect assembly of the speaker connector that can cause device cables to become loose or disconnected, resulting in loss of speaker output. The monitor was distributed nationwide in the US and in numerous countries worldwide. This is a Class II recall affecting a medical device used for fetal monitoring.
- Recalling firm
- Philips North America Llc
- Product
- Philips Avalon Fetal Monitor, FM 30 Part numberM2703A
- Reason
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-26
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/57390db2-c615-46bf-aafa-8119cdab8920