GE Healthcare LOGIQ F R3 Ultrasound System — Class II medical device recall Z-2029-2025
Ongoing recall by GE Medical Systems China Co., Ltd., reported 2025-07-02. GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana P
| Recall number | Z-2029-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems China Co., Ltd., Wuxi, China |
| Recall initiated | 2025-05-16 |
| Classified | 2025-06-26 |
| Reported by FDA | 2025-07-02 |
| Quantity | 34 units |
| UPC / GTIN / UDI-DI | 00195278722430 |
| Serial numbers | 6310007WX0, 6310008WX0, 6310009WX0, 6310010WX0, 6310011WX0, 6310012WX0, 6310013WX0, 6310014WX0, 6310015WX0, 6310016WX0, 6310017WX0, 6310018WX0, 6310019WX0, 6310020WX0, 6310021WX0, 6310023WX0, 6310024WX0, 6310025WX0, 6310026WX0, 6310027WX0, 6310028WX0, 6310029WX0, 6310031WX0, 6310032WX0, 6310033WX0 and 9 more |
| Model numbers | 5943263 |
Product
GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system
Reason for recall
GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previous obstetric patient data in the Whizz report. This could potentially lead to an incorrect clinical decision due to inaccuracy in the fetal size and growth calculation.
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-2029-2025. 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.