Class II

Medical Device Recall: GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system

GE Medical Systems China Co., Ltd. · May 16, 2025

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

Worldwide distribution.

Quantity Affected

34 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2029-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

GE Medical Systems China Co., Ltd. Medical Device Recall: GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system | SafeCheck