FDA Medical devices recall · July 2, 2025

GE Healthcare Versana Ultrasound Systems, sold under the following names… recall

Read the official FDA notice ↗

Product

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

Why was it 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.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

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(1

Distribution

Worldwide distribution.

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-2030-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.