Recall archive / FDA device enforcement
GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system — FDA record Z-2029-2025
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 LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, 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
- 34 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2029-2025
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 | UDI/DI 00195278722430, Lot/Serial Numbers: 6310028WX0, 6310008WX0, 6310041WX0, 6310017WX0, 6310031WX0, 6310044WX0, 6310024WX0, 6310038WX0, 6310040WX0, 6310019WX0, 6310018WX0, 6310023WX0, 6310033WX0, 6310012WX0, 6310026WX0, 6310020WX0, 6310032WX0, 6310014WX0, 6310021WX0, 6310025WX0, 6310010WX0, 6310027WX0, 6310037WX0, 6310009WX0, 6310007WX0, 6310035WX0, 6310016WX0, 6310039WX0, 6310036WX0, 6310043WX0, 6310011WX0, 6310015WX0, 6310013WX0, 6310029WX0. |
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.