FDA-Device2024-12-11Class II

GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography system

GE Healthcare (China) Co., Ltd.
Hazard

GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur.

Sold states
Worldwide distribution.
Affected count
8 units
Manufactured in
1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area, Beijing, China
Products
GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography system

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0602-2025

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