Recall Z-0605-2025 ยท JAK System, X-Ray, Tomography, Computed
GE Healthcare (China) Co., Ltd.
GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography system
| Date | Dec 4, 2024 (initiated Nov 5, 2024) |
| Status | Open, Classified |
| 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 |
| Root cause | Component design/selection |
| Action | GE HealthCare issued an URGENT MEDICAL DEVICE notice to its consignees on 11/05/2024 via mailing using a traceable means. The notice explained the issue, potential safety issue, and requested the following actions be taken: " You can continue to use your system. When utilizing helical, cine, and cardiac scan modes, review the image data set for any potential rotation. When using these modes during interventional procedures or radiation therapy planning, adhere to standard clinical quality checks and workflows. If image rotation is detected, consult with the physician to determine whether a |
| Quantity | 16 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K213938 | Revolution Ascend Ge Healthcare Japan Corporation, Feb 4, 2022 |