CT Image Rotation Issue in GE Healthcare Optima 680 Systems
GE Healthcare Optima 680 Expert CT systems may produce progressively rotated images during helical and cardiac scans. Affected images may require rescanning for accurate clinical interpretation.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II medical device recall with no reported illnesses, injuries, or deaths. The hazard is a detectable image-quality issue (progressive rotation) that does not distort anatomical information and is correctable through standard clinical rescanning procedures.
Plain-English summary
GE Healthcare has identified a potential issue affecting certain Discovery, Optima, and Revolution series CT systems where CT images become progressively rotated during scans. In helical, cine, and cardiac scan modes, each image after the first can be rotated by an increasing amount, with maximum rotation reaching approximately 56 degrees.
The degree of rotation depends on gantry speed and scan duration. While the entire anatomy rotates uniformly without distortion and anatomical positioning remains correct, image rotation may not be immediately noticeable in small amounts. If detected and requiring rescanning, the same rotation pattern will recur.
Eight units of the Optima 680 Expert (Model 6670000, UDI/DI 00840682146937) are affected, with worldwide distribution. Affected serial numbers are: CBDXG2400054HM, CBDXG2400059HM, CBDXG2400055HM, CBDXG2400058HM, CBDXG2400057HM, CBDXG2400060HM, CBDXG2400061HM, and CBDXG2400056HM.
Healthcare facilities using affected systems should monitor CT images for rotation artifacts and contact GE Healthcare for technical support. No injuries or adverse events have been reported. Facilities should maintain standard image quality review and verification procedures.
The recalled product
- Product
- GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography system
- Manufacturer
- GE Healthcare (China) Co., Ltd.
- Hazard
- image-rotation
- imaging-artifact
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- UDI/DI 00840682146937
- Serial/Sales Order Numbers: CBDXG2400054HM
- CBDXG2400059HM
- CBDXG2400055HM
- CBDXG2400058HM
- CBDXG2400057HM
- CBDXG2400060HM
- CBDXG2400061HM
- CBDXG2400056HM
Distribution
Distribution scope not specified by the agency.
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