Reported Jul 2, 2025 · Ongoing
GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system
GE Medical Systems China Co., Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Medical Systems China Co., Ltd. · Dev. Zone · Wuxi · N/A
Is this the product you have?
GE Healthcare LOGIQ F R3 Ultrasound SystemModel/Catalog Number 5943263diagnostic ultrasound system
- Lot codes and dates
- UDI/DI 00195278722430
- Lot/Serial Numbers
6310028WX06310008WX06310041WX06310017WX06310031WX06310044WX06310024WX06310038WX06310040WX06310019WX06310018WX06310023WX06310033WX06310012WX06310026WX06310020WX06310032WX06310014WX06310021WX06310025WX06310010WX06310027WX06310037WX06310009WX06310007WX06310035WX06310016WX06310039WX06310036WX06310043WX06310011WX06310015WX06310013WX06310029WX0
- Amount recalled
- 34 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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