Philips North America Llc: System, Monitoring, Perinatal
Philips is recalling certain Avalon Fetal Monitor models (FM20, part numbers M2702A and M2703A) because of an assembly problem with the speaker connector that can cause cables to disconnect, potentially resulting in loss of audio output. The monitors were distributed nationwide in the US and in numerous countries worldwide. This is a Class II recall, meaning the defect could cause serious health consequences but is unlikely to result in death.
- Recalling firm
- Philips North America Llc
- Product
- Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A
- 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/408ee17a-2686-406d-8939-907a88ff81ca