GE Healthcare CT Imaging Systems Recalled for Progressive Image Rotation
GE Healthcare is recalling operator console upgrades for certain CT systems due to a software defect causing progressive image rotation during scans. Rotations can reach up to 56 degrees and may require patient rescanning.
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 addresses a software defect affecting image orientation in CT systems. No illnesses or injuries have been reported. The hazard is a diagnostic quality issue rather than a direct patient safety threat, and the defect is detectable and correctable through rescanning.
Plain-English summary
GE Healthcare has issued a recall for Operator Console Upgrade Type FRU Spare Parts Number B80212DA, which affects certain CT imaging systems including the Discovery, Optima, and Revolution series models, as well as BrightSpeed Elite and BrightSpeed Elite Select systems. A total of 4 units with serial numbers 203364, 8102303, 5468897, and 5469818 have been identified. The recall affects equipment distributed worldwide.
A software defect in the operator console can cause CT scan images to progressively rotate during examinations, particularly in helical, cine, and cardiac scan modes. After the first image of an exam, each subsequent image can rotate by an increasing amount, with the final image potentially rotated up to approximately 56 degrees. The amount of rotation is dependent on gantry speed and scan duration. The entire anatomy rotates as a unit by equal degrees without distortion, and the anatomical positioning and z-axis information of the images remains correct.
Small degrees of image rotation might not be detected during routine quality review. If image rotation is identified and requires a patient rescan, the same rotation pattern will occur in the rescheduled examination. GE Healthcare has become aware of this potential issue and initiated this recall to address the defect.
The recalled product
- Product
- GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80212DA: EU: Operator Console (for BrightSpeed, Elite/BrightSpeed Elite Select), Non-EU: BrightSpeed Elite, BrightSpeed Elite Select; X-ray/computed tomography system
- Manufacturer
- GE Healthcare (China) Co., Ltd.
- Category
- Medical Device — CT Scanner
- Hazard
- image-rotation
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 (5)
- UDI/DI 00195278505798
- Serial/Sales Order Numbers: 203364
- 8102303
- 5468897
- 5469818
Distribution
Distribution scope not specified by the agency.
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