Philips North America LLC recalls Philips Avalon Fetal Monitor

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.

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."

• FDA enforcement recordOfficial FDA database entry for Z-2523-2026
• FDA 510(k) clearance · K140535The device's official FDA premarket clearance record
• FDA device classification · HGMOfficial FDA classification for this device type
• CFR regulation · 21 CFR 884.2740The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Philips North America LlcSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.