Recall Z-2021-2021 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 projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, liver, kidney, pancreas, etc. The system may acquire data using Axial, Cine, Heli
| 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 |