FDA Device recall Z-0608-2025
GE Healthcare Revolution EVO, Model Number 5454001-260
- FDA Device
- Class II
- ongoing
- Published 2024-12-11
On 2024-12-11 the FDA classified a Class II recall of GE Healthcare Revolution EVO, Model Number 5454001-260 by Ge Healthcare China, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0608-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-05 |
| Published | 2024-12-11 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ge Healthcare China |
| Distribution | n/a |
Product
GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography system
Reason
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.
Identifiers
| code_info | UDI/DI 00840682109796, Serial/Sales Order Numbers: CBDGG2400018HM, CBDGG2400017HM |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0608-2025%22
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