Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

GE Healthcare LOGIQ F R3 Ultrasound System Recalled by GE Medical Systems China Co., Ltd. Due to GE HealthCare has become aware that the Estimated...

Date: May 16, 2025
Company: GE Medical Systems China Co., Ltd.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact GE Medical Systems China Co., Ltd. directly.

Affected Products

GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system

Quantity: 34 units

Why Was This 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.

Where Was This Sold?

Worldwide distribution.

About GE Medical Systems China Co., Ltd.

GE Medical Systems China Co., Ltd. has 26 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report