Philips North America Llc: Philips Avalon Fetal Monitor, Fm 30 Part Numberm2703a

Recall Summary Philips is recalling Avalon Fetal Monitor model FM 30 (part number M2703A) due to an assembly defect in the speaker connector that can cause cables to disconnect from the device housing, potentially resulting in loss of speaker output. The monitor was distributed worldwide, including throughout all U.S. states and numerous countries. This is a Class II recall, meaning the defect could cause temporary or permanent loss of function but poses a lower level of risk.

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
U.S. Food and Drug Administration
Recall date
2026-05-26
Status
Ongoing
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 U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/08382d28-d224-4d46-8406-46007f46c021