FDA Device recall Z-2030-2025
GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier R3 VS, Model/Catalog…
- FDA Device
- Class II
- ongoing
- Published 2025-07-02
On 2025-07-02 the FDA classified a Class II recall of GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier R3 VS, Model/Catalog… by Ge Medical Systems China, citing 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 previo….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2030-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-16 |
| Published | 2025-07-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ge Medical Systems China |
| Distribution | n/a |
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
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.
Identifiers
| code_info | Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241127(21)6302036WX0, Lot/Serial Number 6302036WX0; Model/C…Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241127(21)6302036WX0, Lot/Serial Number 6302036WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241127(21)6302045WX0, Lot/Serial Number 6302045WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241127(21)6302035WX0, Lot/Serial Number 6302035WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241127(21)6302046WX0, Lot/Serial Number 6302046WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241127(21)6302033WX0, Lot/Serial Number 6302033WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241127(21)6302034WX0, Lot/Serial Number 6302034WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241127(21)6302041WX0, Lot/Serial Number 6302041WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241127(21)6302040WX0, Lot/Serial Number 6302040WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241127(21)6302039WX0, Lot/Serial Number 63020 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2030-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.