GE Healthcare Versana Ultrasound Systems — Class II medical device recall Z-2030-2025
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-2030-2025 |
|---|---|
| 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 | 792 units |
| UPC / GTIN / UDI-DI | 00195278644350, 00195278645562, 00195278690388, 00195278690395, 00195278690401, 00195278690418, 00195278752550, 00195278752567, 00195278758545, 00195278758552, 00195278758651, 00195278758668, 00195278758675, 00195278758699, 00195278758712, 00195278758729 |
| Lot numbers | 4PP, 5PP |
| Serial numbers | 6302027WX0, 6302028WX0, 6302029WX0, 6302030WX0, 6302031WX0, 6302032WX0, 6302033WX0, 6302034WX0, 6302035WX0, 6302036WX0, 6302037WX0, 6302038WX0, 6302039WX0, 6302040WX0, 6302041WX0, 6302042WX0, 6302043WX0, 6302044WX0, 6302045WX0, 6302046WX0, 6302047WX0, 6302070WX0, 6302072WX0, 6302073WX0, 6302075WX0 and 475 more |
| Model numbers | 5938558, 5938559, 5938560, 5938561, 5946387, 5946481, 5946950, 5946951, 5946952, 5946953, 5946954, 5946955, 5946956, 5946957, 5948398, 5948399 |
Product
GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier R3 VS, Model/Catalog Number 5938558; 2) Versana Premier R3 VA, Model/Catalog Number 5938559; 3) Versana Premier Lotus 4PP, Model/Catalog Number 5938560; 4) Versana Premier Lotus 5PP, Model/Catalog Number 5938561; 5) Versana Premier R3 VA Vet, Model/Catalog Number 5946387; 6) Versana Premier R3 VS Vet, Model/Catalog Number 5946481. 7) Versana Premier R3 Expert, Model/Catalog Number 5946950; 8) Versana Premier R3, Model/Catalog Number 5946951; 9) Versana Premier R3 Pro, Model/Catalog Number 5946952; 10) Versana Premier R3 Elite, Model/Catalog Number 5946953; 11) Versana Premier R3 Plus, Model/Catalog Number 5946954; 12) Versana Premier R3 Ultra, Model/Catalog Number 5946955; 13) Versana Premier R3 Max, Model/Catalog Number 5946956; 14) Versana Premier R3 Super, Model/Catalog Number 5946957; 15) Versana Premier R3 VS India, Model/Catalog Number 5948398; 16) Versana Premier R3 VA India, Model/Catalog Number 5948399; 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-2030-2025. 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.