GE Healthcare recalls operator console upgrades (B80212DA) for certain CT systems due to potential image rotation during scans. Affected units may show progressively rotated images, requiring rescan if noticed.
GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur.
GE Healthcare is recalling specific operator console upgrades for certain CT scanners because they can cause images to rotate progressively during scans. This rotation increases with each image and may require a rescan if noticed, potentially leading to repeated issues.
The operator console upgrade can cause CT images to rotate progressively after the first scan image. This rotation increases with each subsequent image and can reach up to 56 degrees. The rotation affects the entire anatomy uniformly without distortion but may require rescan if noticed.
Users of GE Healthcare CT systems with the specific operator console upgrade (B80212DA) are affected. Patients undergoing scans on these systems may experience rotated images, but the risk of serious harm is minimal.
Check for the FRU Spare Parts Number B80212DA on the operator console. Affected units include GE BrightSpeed Elite and BrightSpeed Elite Select CT systems sold in the EU and non-EU regions with specific serial numbers.
Identify the operator console model and check for the FRU Spare Parts Number B80212DA.
GE Healthcare has identified a potential issue with certain operator console upgrades that can cause CT images to rotate progressively during scans.
After the first image, each subsequent image can rotate by an increasing amount, up to 56 degrees. This rotation affects the entire anatomy uniformly but may require a rescan if noticed.
The recall record does not specify a remedy or fix for the issue.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0614-2025 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0614-2025 from GE Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
