Recall Z-2029-2025— GE Medical Systems China Co., Ltd.

Name: FDA recall Z-2029-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-16

Class II · Ongoing

Class II FDA medical device recall by GE Medical Systems China Co., Ltd., initiated 2025-05-16. It names one FDA 510(k) clearance: K242005. 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..

Recalling firm: GE Medical Systems China Co., Ltd.
Classification: Class II
Status: Ongoing
Initiated: 2025-05-16
Firm location: Wuxi, China

510(k) clearances named in this recall

1 on FDA's record

K242005 — Versana Premier; Versana Premier Lotus; LOGIQ FGE Medical Systems Ultrasound and Primary Care Diagnostics·cleared 2024-10-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.