Recall Z-2030-2025 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
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) 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
| Date | Jun 26, 2025 (initiated May 16, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software design (manufacturing process) |
| Action | GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 05/16/2025 via letter delivered using a traceable means. The notice explained the issue, potential risk, and requested the following: "Actions to be taken by Customer/User: You may continue to use your Versana Premier R3 and LOGIQ F R3 series ultrasound systems by following the actions below: 1) If you use the Whizz report feature, reboot the system after finishing each obstetric patient examination. OR 2) Instead of using the Whizz report feature, after completing an obstetric patient examination, |
| Quantity | 792 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K242005 | Versana Premier; Versana Premier Lotus; LOGIQ F GE Medical Systems Ultrasound and Primary Care Diagnostics, Oct 2, 2024 |