GE Healthcare CT Scanner Console Images May Rotate After First Scan
Certain GE Healthcare CT scanner systems may produce progressively rotated images after the first scan, with rotation up to 56 degrees. While anatomical data remains intact, misaligned images could necessitate patient rescans.
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: This FDA Class II recall reports no illnesses or injuries. The hazard is diagnostic imaging accuracy impairment (progressive image rotation) that could necessitate patient rescans but does not directly cause physical harm. Anatomical data integrity is maintained.
Plain-English summary
GE Healthcare has identified a potential issue affecting certain Discovery, Optima, and Revolution series CT scanner systems, as well as certain operator console upgrades (FRU Spare Parts Number B80662DA). The affected equipment was distributed worldwide.
The issue involves image rotation in helical, cine, and cardiac scan modes. Beginning with the second image of an exam, subsequent images progressively rotate by increasing amounts. The degree of rotation depends on gantry speed and scan duration, with maximum rotation reaching approximately 56 degrees. The entire anatomy rotates uniformly without geometric distortion, and anatomical positioning and z-axis alignment remain correct.
Operators may not notice small degrees of image rotation. If rotation is detected and a patient rescan is performed, the same rotation pattern will occur on the rescanned images. GE Healthcare recommends that facilities using affected equipment contact them for further guidance and potential remediation options.
The recalled product
- Product
- GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80662DA: China Only: Discovery CT750HD
- Manufacturer
- GE Healthcare (China) Co., Ltd.
- Hazard
- image-rotation
- diagnostic-error
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 (2)
- UDI/DI N/A
- Serial/Sales Order Numbers: 5472442
Distribution
Distribution scope not specified by the agency.
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