GE Healthcare Versana Ultrasound Systems
Medical device recall Z-2030-2025. Published in FDA’s Enforcement Report on Jul 2, 2025.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 2, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Not named no state, in where it went
- 792 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier R3 VS, Model/Catalog Number 5938558; 2) Versana Premier R3 VA, Model/Catalog Number 5938559; 3) Versana Premier Lotus 4PP, Model/Catalog Number 5938560; 4) Versana Premier Lotus 5PP, Model/Catalog Number 5938561; 5) Versana Premier R3 VA Vet, Model/Catalog Number 5946387; 6) Versana Premier R3 VS Vet, Model/Catalog Number 5946481. 7) Versana Premier R3 Expert, Model/Catalog Number 5946950; 8) Versana Premier R3, Model/Catalog Number 5946951; 9) Versana Premier R3 Pro, Model/Catalog Number 5946952; 10) Versana Premier R3 Elite, Model/Catalog Number 5946953; 11) Versana Premier R3 Plus, Model/Catalog Number 5946954; 12) Versana Premier R3 Ultra, Model/Catalog Number 5946955; 13) Versana Premier R3 Max, Model/Catalog Number 5946956; 14) Versana Premier R3 Super, Model/Catalog Number 5946957; 15) Versana Premier R3 VS India, Model/Catalog Number 5948398; 16) Versana Premier R3 VA India, Model/Catalog Number 5948399; diagnostic ultrasound system
792 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241127(21)6302036WX0, Lot/Serial Number 6302036WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241127(21)6302045WX0, Lot/Serial Number 6302045WX0; Model/Catalog…
Every code shown here, 1,998 characters
Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241127(21)6302036WX0, Lot/Serial Number 6302036WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241127(21)6302045WX0, Lot/Serial Number 6302045WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241127(21)6302035WX0, Lot/Serial Number 6302035WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241127(21)6302046WX0, Lot/Serial Number 6302046WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241127(21)6302033WX0, Lot/Serial Number 6302033WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241127(21)6302034WX0, Lot/Serial Number 6302034WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241127(21)6302041WX0, Lot/Serial Number 6302041WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241127(21)6302040WX0, Lot/Serial Number 6302040WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241127(21)6302039WX0, Lot/Serial Number 6302039WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241127(21)6302044WX0, Lot/Serial Number 6302044WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241127(21)6302043WX0, Lot/Serial Number 6302043WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241127(21)6302038WX0, Lot/Serial Number 6302038WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241127(21)6302037WX0, Lot/Serial Number 6302037WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241127(21)6302047WX0, Lot/Serial Number 6302047WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241127(21)6302042WX0, Lot/Serial Number 6302042WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)241125(21)6302029WX0, Lot/Serial Number 6302029WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)250214(21)6302080WX0, Lot/Serial Number 6302080WX0; Model/Catalog Number 5938558, UDI/DI (01)00195278690388(11)250214(21)6302081WX0, Lot/Serial Number 6302081WX0;…
FDA’s list runs to 87,217 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution.
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 16, 2025.
- FDA classified it on Jun 26, 2025.
- FDA’s Enforcement Report published it on Jul 2, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Medical Systems China Co., Ltd., of Wuxi, China.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 87,217 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.