Official recall record
GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography system
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2024-11-05
- Country of alert
- China
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00840682146173
- Brand on record
- GE Healthcare (China) Co., Ltd.
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.
Same barcode in other registries
The same EAN appears in 1 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2026-03-26 · US FDA — Medical Devices
Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300
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