FDA recall Z-2029-2025

GE Medical Systems China Co., Ltd. · Class II · device

Product

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

Worldwide distribution.

Key facts

Status: Ongoing
Initiation date: 2025-05-16
Report date: 2025-07-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Wuxi, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2029-2025