GE Medical Systems China Co., Ltd.: GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier R3 VS, Model/Catalog Number 5938558; 2) Versa

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide distribution. Quantity: 792 units Lot/code info: 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

UPC codes

00195278690388, 00195278690395

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.