GE Healthcare CT Operator Console Update: Images May Rotate Progressively
GE Healthcare operator console upgrades for certain CT systems can cause progressive image rotation during scans. Images may rotate up to 56 degrees per exam, potentially affecting diagnostic accuracy.
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: This FDA Class II recall affects a medical imaging device where progressive image rotation could compromise diagnostic accuracy. No hospitalizations, injuries, or adverse events are reported. The classification as a risk-of-harm product without reported injury places it at High severity per the rubric.
Plain-English summary
GE Healthcare has identified a potential issue affecting certain Discovery, Optima, and Revolution series CT systems, as well as specific operator console upgrades (FRU Spare Parts Number B80522DA). The issue can result in progressive rotation of CT images during helical, cine, and cardiac scan modes.
During scans, the first image displays normally, but each subsequent image rotates by an increasing amount. The degree of rotation depends on gantry speed and scan duration, with images potentially rotating up to approximately 56 degrees by the end of an examination. The entire anatomy rotates as a unit without distortion, and anatomical positioning and z-axis alignment remain correct.
Healthcare providers using affected systems should be aware that small image rotations may not be immediately obvious. If image rotation is detected and a rescan becomes necessary, the same rotation pattern will recur. Affected units have serial/sales order numbers 5476353, 5472107, and 5472476.
Contact GE Healthcare for guidance on verification and potential corrective actions.
The recalled product
- Product
- GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA: China Only: Revolution Discovery CT
- Manufacturer
- GE Healthcare (China) Co., Ltd.
- Hazard
- image-rotation
- diagnostic-accuracy-risk
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 (4)
- UDI/DI 00840682102490
- Serial/Sales Order Numbers: 5476353
- 5472107
- 5472476
Distribution
Distribution scope not specified by the agency.
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