Data Foundry

Medical device recalls 2024

Avalon Ultrasound Transducer — Class II medical device recall Z-2239-2024

Ongoing recall by Philips North America Llc, reported 2024-07-10, distributed nationwide. Potential for inaccurate fetal heart rate measurements when monitoring multiples.

Recall numberZ-2239-2024
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmPhilips North America Llc, Cambridge, MA, United States
Recall initiated2024-05-22
Classified2024-06-28
Reported by FDA2024-07-10
DistributedNationwide (US)
Quantity6,915 units
UPC / GTIN / UDI-DI00884838093195
Serial numbersDE67535433, DE67535436, DE67535443, DE67535447, DE67535452, DE67535462, DE67535463, DE67535464, DE67535470, DE67535471, DE67535474, DE67535476, DE67535479, DE67535480, DE67535483, DE67535484, DE67535487, DE67535488, DE67535499, DE67535502, DE67535507, DE67535508, DE67535518, DE67535521, DE67535523 and 475 more
Model numbers867246

Product

Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heart rate.

Reason for recall

Potential for inaccurate fetal heart rate measurements when monitoring multiples.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2239-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.