GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography system Recall
Issued December 11, 2024 · GE Healthcare (China) Co., Ltd.
In December 2024, GE Healthcare (China) Co., Ltd. recalled the GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography system, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography system right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact GE Healthcare (China) Co., Ltd. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Recall details
- Brand
- GE Healthcare (China) Co., Ltd.
- Category
- Health
- Recall date
- December 11, 2024
- Units affected
- Not reported
- Sold at
- Worldwide distribution.
- Recall number
- FDA-Z-0602-2025
- Made in
- China
- Issuing agency
- FDA
In context
- GE Healthcare (China) Co., Ltd. has 5 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.