Reported Jul 2, 2025 · Ongoing
GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier…
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?
292 of 292 products
| Model / number | Barcodes | Product as published |
|---|---|---|
5938558 | 00195278690388 | Model/ , UDI/DI (01)00195278690388(11)241127(21)6302036WX0, Lot/Serial Number 6302036WX0 |
5938558 | 00195278690388 | Model/ , UDI/DI (01)00195278690388(11)241127(21)6302045WX0, Lot/Serial Number 6302045WX0 |
5938558 | 00195278690388 | Model/ , UDI/DI (01)00195278690388(11)241127(21)6302035WX0, Lot/Serial Number 6302035WX0 |
5938558 | 00195278690388 | Model/ , UDI/DI (01)00195278690388(11)241127(21)6302046WX0, Lot/Serial Number 6302046WX0 |
5938558 | 00195278690388 | Model/ , UDI/DI (01)00195278690388(11)241127(21)6302033WX0, Lot/Serial Number 6302033WX0 |
5938558 | 00195278690388 | Model/ , UDI/DI (01)00195278690388(11)241127(21)6302034WX0, Lot/Serial Number 6302034WX0 |
5938558 | 00195278690388 | Model/ , UDI/DI (01)00195278690388(11)241127(21)6302041WX0, Lot/Serial Number 6302041WX0 |
5938558 | 00195278690388 | Model/ , UDI/DI (01)00195278690388(11)241127(21)6302040WX0, Lot/Serial Number 6302040WX0 |
5938558 | 00195278690388 | Model/ , UDI/DI (01)00195278690388(11)241127(21)6302039WX0, Lot/Serial Number 6302039WX0 |
5938558 | 00195278690388 | Model/ , UDI/DI (01)00195278690388(11)241127(21)6302044WX0, Lot/Serial Number 6302044WX0 |
5938558 | 00195278690388 | Model/ , UDI/DI (01)00195278690388(11)241127(21)6302043WX0, Lot/Serial Number 6302043WX0 |
5938558 | 00195278690388 | Model/ , UDI/DI (01)00195278690388(11)241127(21)6302038WX0, Lot/Serial Number 6302038WX0 |
5938558 | 00195278690388 | Model/ , UDI/DI (01)00195278690388(11)241127(21)6302037WX0, Lot/Serial Number 6302037WX0 |
5938558 | 00195278690388 | Model/ , UDI/DI (01)00195278690388(11)241127(21)6302047WX0, Lot/Serial Number 6302047WX0 |
5938558 | 00195278690388 | Model/ , UDI/DI (01)00195278690388(11)241127(21)6302042WX0, Lot/Serial Number 6302042WX0 |
5938558 | 00195278690388 | Model/ , UDI/DI (01)00195278690388(11)241125(21)6302029WX0, Lot/Serial Number 6302029WX0 |
5938558 | 00195278690388 | Model/ , UDI/DI (01)00195278690388(11)250214(21)6302080WX0, Lot/Serial Number 6302080WX0 |
5938558 | 00195278690388 | Model/ , UDI/DI (01)00195278690388(11)250214(21)6302081WX0, Lot/Serial Number 6302081WX0 |
5938558 | 00195278690388 | Model/ , UDI/DI (01)00195278690388(11)250214(21)6302078WX0, Lot/Serial Number 6302078WX0 |
5938558 | 00195278690388 | Model/ , UDI/DI (01)00195278690388(11)250214(21)6302079WX0, Lot/Serial Number 6302079WX0 |
- Amount recalled
- 792 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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