FDA recall Z-2522-2026

Product

Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A

Reason for recall

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.

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.

Key facts

Status

Ongoing

Initiation date

2026-05-26

Report date

2026-07-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2522-2026