GE HealthCare has recalled 172 units of Discovery, Optima, and Revolution series CT systems and specific operator console upgrades because images may appear rotated. This defect occurs primarily in helical, cine, and cardiac scan modes, where each subsequent image rotates by an increasing amount, reaching up to 56 degrees. While the anatomy rotates as a whole without distortion, small degrees of rotation may be difficult to detect, potentially leading to incorrect diagnosis. No injuries or incidents have been reported, but the defect may require patients to undergo rescans, resulting in unnecessary radiation exposure.
The defect causes CT images to rotate progressively by as much as 56 degrees depending on the gantry speed and scan duration. This rotation can lead to the misinterpretation of anatomical positioning or necessitate repeat imaging, which exposes patients to additional radiation.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES ยท Raw API Response
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