Recall archive / FDA device enforcement
GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premie... — FDA record Z-2030-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 16, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- GE Medical Systems China Co., Ltd.
- Quantity
- 792 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2030-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 6302039WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241127(21)6302044WX0, Lot/Serial Number 6302044WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241127(21)6302043WX0, Lot/Serial Number 6302043WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241127(21)6302038WX0, Lot/Serial Number 6302038WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241127(21)6302037WX0, Lot/Serial Number 6302037WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241127(21)6302047WX0, Lot/Serial Number 6302047WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241127(21)6302042WX0, Lot/Serial Number 6302042WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241125(21)6302029WX0, Lot/Serial Number 6302029WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)250214(21)6302080WX0, Lot/Serial Number 6302080WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)250214(21)6302081WX0, Lot/Serial Number 6302081WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)250214(21)6302078WX0, Lot/Serial Number 6302078WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)250214(21)6302079WX0, Lot/Serial Number 6302079WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)250214(21)6302077WX0, Lot/Serial Number 6302077WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)250108(21)6302073WX0, Lot/Serial Number 6302073WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)250107(21)6302070WX0, Lot/Serial Number 6302070WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)250107(21)6302072WX0, Lot/Serial Number 6302072WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)250310(21)6302087WX0, Lot/Serial Number 6302087WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)250228(21)6302083WX0, Lot/Serial Number 6302083WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241125(21)6302030WX0, Lot/Serial Number 6302030WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241125(21)6302028WX0, Lot/Serial Number 6302028WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241125(21)6302031WX0, Lot/Serial Number 6302031WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241125(21)6302032WX0, Lot/Serial Number 6302032WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)250117(21)6302075WX0, Lot/Serial Number 6302075WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241031(21)6302027WX0, Lot/Serial Number 6302027WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)250205(21)6302076WX0, Lot/Serial Number 6302076WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)241107(21)6304133WX0, Lot/Serial Number 6304133WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)241126(21)6304157WX0, Lot/Serial Number 6304157WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)241206(21)6304193WX0, Lot/Serial Number 6304193WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)241202(21)6304163WX0, Lot/Serial Number 6304163WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)241230(21)6304218WX0, Lot/Serial Number 6304218WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)241107(21)6304132WX0, Lot/Serial Number 6304132WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)240929(21)6304073WX0, Lot/Serial Number 6304073WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)240927(21)6304071WX0, Lot/Serial Number 6304071WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)241218(21)6304214WX0, Lot/Serial Number 6304214WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)241230(21)6304219WX0, Lot/Serial Number 6304219WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)241206(21)6304183WX0, Lot/Serial Number 6304183WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)241202(21)6304162WX0, Lot/Serial Number 6304162WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)241202(21)6304164WX0, Lot/Serial Number 6304164WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)240929(21)6304072WX0, Lot/Serial Number 6304072WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)241022(21)6304089WX0, Lot/Serial Number 6304089WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)241022(21)6304091WX0, Lot/Serial Number 6304091WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)241022(21)6304094WX0, Lot/Serial Number 6304094WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)241022(21)6304101WX0, Lot/Serial Number 6304101WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)240821(21)6304029WX0, Lot/Serial Number 6304029WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)241106(21)6304124WX0, Lot/Serial Number 6304124WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)250208(21)6304282WX0, Lot/Serial Number 6304282WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)241022(21)6304097WX0, Lot/Serial Number 6304097WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)241209(21)6304211WX0, Lot/Serial Number 6304211WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)241024(21)6304109WX0, Lot/Serial Number 6304109WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)241126(21)6304154WX0, Lot/Serial Number 6304154WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)241018(21)6304086WX0, Lot/Serial Number 6304086WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)241127(21)6304158WX0, Lot/Serial Number 6304158WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)241127(21)6304159WX0, Lot/Serial Number 6304159WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)241126(21)6304156WX0, Lot/Serial Number 6304156WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)241024(21)6304021WX0, Lot/Serial Number 6304021WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)241126(21)6304155WX0, Lot/Serial Number 6304155WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)241024(21)6304110WX0, Lot/Serial Number 6304110WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)241024(21)6304107WX0, Lot/Serial Number 6304107WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)250219(21)6304333WX0, Lot/Serial Number 6304333WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)250224(21)6304368WX0, Lot/Serial Number 6304368WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)250221(21)6304367WX0, Lot/Serial Number 6304367WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)250224(21)6304369WX0, Lot/Serial Number 6304369WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)250115(21)6304255WX0, Lot/Serial Number 6304255WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)250115(21)6304263WX0, Lot/Serial Number 6304263WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)250115(21)6304270WX0, Lot/Serial Number 6304270WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)250115(21)6304269WX0, Lot/Serial Number 6304269WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)250115(21)6304258WX0, Lot/Serial Number 6304258WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)250115(21)6304262WX0, Lot/Serial Number 6304262WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)250115(21)6304259WX0, Lot/Serial Number 6304259WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)240822(21)6304056WX0, Lot/Serial Number 6304056WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)250213(21)6304311WX0, Lot/Serial Number 6304311WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)250212(21)6304309WX0, Lot/Serial Number 6304309WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)250313(21)6304399WX0, Lot/Serial Number 6304399WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)240822(21)6304047WX0, Lot/Serial Number 6304047WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)241015(21)6304079WX0, Lot/Serial Number 6304079WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)241015(21)6304078WX0, Lot/Serial Number 6304078WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)241108(21)6304139WX0, Lot/Serial Number 6304139WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)241209(21)6304208WX0, Lot/Serial Number 6304208WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)250103(21)6304226WX0, Lot/Serial Number 6304226WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)250220(21)6304346WX0, Lot/Serial Number 6304346WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)250220(21)6304345WX0, Lot/Serial Number 6304345WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)240821(21)6304035WX0, Lot/Serial Number 6304035WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)241204(21)6304167WX0, Lot/Serial Number 6304167WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)241108(21)6304138WX0, Lot/Serial Number 6304138WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)241029(21)6304112WX0, Lot/Serial Number 6304112WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)241029(21)6304113WX0, Lot/Serial Number 6304113WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)250214(21)6304314WX0, Lot/Serial Number 6304314WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)250214(21)6304315WX0, Lot/Serial Number 6304315WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)250214(21)6304316WX0, Lot/Serial Number 6304316WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)250214(21)6304317WX0, Lot/Serial Number 6304317WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)250214(21)6304318WX0, Lot/Serial Number 6304318WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)250314(21)6304413WX0, Lot/Serial Number 6304413WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)250314(21)6304414WX0, Lot/Serial Number 6304414WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)250314(21)6304415WX0, Lot/Serial Number 6304415WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)250314(21)6304416WX0, Lot/Serial Number 6304416WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)250314(21)6304417WX0, Lot/Serial Number 6304417WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)241030(21)6304111WX0, Lot/Serial Number 6304111WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)241209(21)6304202WX0, Lot/Serial Number 6304202WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)250208(21)6304294WX0, Lot/Serial Number 6304294WX0; Model/Catalog Number 5938559, UDI/DI (01)00195278690395(11)241206(21)6304200WX0, Lot/Serial Number 6304200WX0; Model/Cat... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jul 2, 2025
- Recall initiation date
- May 16, 2025
- Center classification date
- Jun 26, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.