Philips Avalon Fetal Monitor, FM 30 Part numberM2703A

FDA device recall Z-2523-2026 · posted 2026-06-22 · Open, Classified

Recall details

Recalling firm

Philips North America Llc

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.

Action taken

Philips issued an URGENT Medical Device Correction notice to its consignees on 5/26/2026 via USPS certified mail. The notice explained the issue and how it can be identified, potential risk to the patient should the loss of audio is not detected, and requested the following: "Actions that should be taken by the customer / user in order to prevent risks for patients or users " Ensure fetal heart rate tones are enabled on the Avalon Fetal Monitor until the planned fix/correction is implemented. " Pass this notice to all those who need to be aware within your organization or to any organization where affected product(s) have been potentially transferred. " Place this Urgent Medical Device Correction with the documentation of the Philips Avalon Fetal Monitor and associated devices in a place where it is most likely to be seen and viewed."

Root cause

Process control

Status

Open, Classified

Product code

HGM

Quantity affected

169 units

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,

Date initiated

2026-05-26

Date posted

2026-06-22

Location

Cambridge, MA

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