Recall Z-2023-2021 ยท JAK System, X-Ray, Tomography, Computed
GE Healthcare, LLC
The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. These images may be obtained either withor without contrast. This device may include signal analysis and display equipment, patient and equipment supports, compo
| Date | Jun 30, 2021 |
| Status | Open, Classified |
| Reason | When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the intended group(s) has been added to the acquisition. |
| Root cause | Process design |
| Distribution | US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203169 | Revolution Ascend Ge Healthcare Japan Corporation, Nov 20, 2020 |