Recall record at a glance
| Official record | Z-0604-2025 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | GE Healthcare (China) Co., Ltd. |
| Report date | Dec 11, 2024 |
| Recall initiation date | Nov 5, 2024 |
| Quantity | 10 units |
| Location | Beijing, China |
Official product description
GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems
Why the product was recalled
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.
Distribution information
Worldwide distribution.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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