Z-2029-2025 Class II Ongoing
FDA device recall Z-2029-2025 was initiated by GE Medical Systems China Co., Ltd. on May 16, 2025 and is designated Class II. 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 … The recall status is ongoing. Affected quantity: 34 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 2, 2025
- Initiation Date
- May 16, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34 units
Product Description
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.
Distribution Pattern
Worldwide distribution.
Code Information
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.