Recall Z-2523-2026— Philips North America Llc

Name: FDA recall Z-2523-2026
Creator: U.S. Food and Drug Administration
Published: 2026-05-26

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2026-05-26. It names one FDA 510(k) clearance: K140535. 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..

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2026-05-26
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K140535 — PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50Philips Medizin Systeme Boblingen GmbH·cleared 2014-11-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Philips Avalon Fetal Monitor, FM 30 Part numberM2703A

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.