FDA-Device2025-07-02Class II
GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system
GE Medical Systems China Co., Ltd.
Hazard
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.
Sold states
Worldwide distribution.
Affected count
34 units
Manufactured in
Dev. Zone, National Hi-Tech; No. 19 Changjiang Road; Xin, Wuxi, China
Products
GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2029-2025Don't want to check this manually?
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