GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier R

FDA device recall Z-2030-2025 · posted 2025-06-26 · Open, Classified

Recall details

Recalling firm

GE Medical Systems China Co., Ltd.

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.

Action taken

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, print all obstetric measurement and calculation results from the worksheet directly. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please retain this document for your records. Please complete and return the attached acknowledgement form to recall.71082@gehealthcare.com." If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.

Root cause

Software design (manufacturing process)

Status

Open, Classified

Product code

IYN

Quantity affected

792 units

Distribution

Worldwide distribution.

Date initiated

2025-05-16

Date posted

2025-06-26

Location

Wuxi, XIN, China

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