FDA-Device2026-07-01Class II

Philips Avalon Fetal Monitor, FM 30 Part numberM2703A

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.

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
169 units
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Philips Avalon Fetal Monitor, FM 30 Part numberM2703A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2523-2026

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