GE Healthcare CT systems produce progressively rotated images in scan modes
Certain GE Healthcare CT systems can produce progressively rotated images during helical and cardiac scans. Images may rotate up to 56 degrees, potentially affecting diagnosis if the rotation is not detected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with a diagnostic imaging defect that could affect patient diagnosis. No illnesses or injuries reported, and anatomical data remains correct. Per rubric, risk-of-harm products without reported injury score High (3).
Plain-English summary
GE Healthcare has identified a potential issue affecting certain CT imaging systems in the Discovery, Optima, and Revolution series that produce progressive image rotation during helical, cine, and cardiac scan modes. Approximately 10 units are affected worldwide.
With these scan modes, the first exam image appears normal, but each subsequent image rotates by an increasing amount—up to approximately 56 degrees in the final image. The rotation amount depends on gantry speed and scan duration. Although anatomical positioning and z-axis information remain correct, the visual rotation could affect diagnostic interpretation if not noticed.
Small rotations may not be immediately obvious. If rotation is detected and a patient rescan is needed, the same rotation pattern will recur on the affected equipment.
The recalled product
- Product
- GE Healthcare Revolution Maxima Select, Model Number, 6670000-55; X-ray/computed tomography system
- 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 (11)
- UDI/DI 00195278520852
- Serial/Sales Order Numbers: CBFSG2400030HM
- CBFSG2400032HM
- CBFSG2400037HM
- CBFSG2400034HM
- CBFSG2400031HM
- CBFSG2400035HM
- CBFSG2400029HM
- CBFSG2400028HM
- CBFSG2400033HM
- CBFSG2400036HM
Distribution
Distribution scope not specified by the agency.
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