[Recalled] GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed tomography system — GE HealthCare has become aware of a potential issue on certain Discovery, Optim… | FDA 2024-11-05
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed tomography system |
|---|---|
| Brand / manufacturer | GE Healthcare (China) Co., Ltd. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0606-2025 |
| Country of notice | China |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 05 November 2024 |
| EAN / barcode | 00195278718129 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in China and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.