GE Medical Systems China Co., Ltd. 2025-07-02 Health serious FDA
Health · FDA · Recall #FDA-Z-2029-2025
GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic… Recall
Issued July 2, 2025 · GE Medical Systems China Co., Ltd.
In July 2025, GE Medical Systems China Co., Ltd. recalled the GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact GE Medical Systems China Co., Ltd. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- GE Medical Systems China Co., Ltd.
- Category
- Health
- Recall date
- July 2, 2025
- Units affected
- Not reported
- Sold at
- Worldwide distribution.
- Recall number
- FDA-Z-2029-2025
- Made in
- China
- Issuing agency
- FDA
In context
- GE Medical Systems China Co., Ltd. has 3 recalls in our database, including 2 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.