GE Healthcare recalls specific Revolution Ascend Elite CT scanners that may produce rotated images during scans, potentially requiring rescan. Affected units have unique serial numbers.
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 certain Revolution Ascend Elite CT scanners that may produce rotated images during scans. This could require patients to undergo rescan if image rotation is noticed, though the rotation doesn't distort anatomy.
The CT scanner may rotate images by up to 56 degrees after the first scan image, especially in helical, cine, and cardiac scans. This rotation repeats if a rescan is needed, but doesn't distort anatomy or change positioning.
Healthcare facilities using the specific model with serial numbers CBFLG2400002HM, CBFLG2400005HM, CBFLG2400004HM, CBFLG2400003HM are affected. Patients may need rescan if image rotation is noticed.
Check for serial numbers CBFLG2400002HM, CBFLG2400005HM, CBFLG2400004HM, or CBFLG2400003HM on the scanner. The model is GE Healthcare Revolution Ascend Elite with specific UDI/DI 00195278718129.
Look for serial numbers CBFLG2400002HM, CBFLG2400005HM, CBFLG2400004HM, or CBFLG2400003HM on the affected CT scanner.
GE Healthcare has identified that certain Revolution Ascend Elite CT scanners may produce rotated images during scans, which could require rescan if noticed.
No, the recall does not require stopping use. The rotation is minor and doesn't distort anatomy, though rescan may be needed if rotation is noticed.
Check for serial numbers CBFLG2400002HM, CBFLG2400005HM, CBFLG2400004HM, or CBFLG2400003HM on the scanner.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0606-2025 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0606-2025 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.