Recall Z-2522-2020 ยท JAK System, X-Ray, Tomography, Computed
Shanghai United Imaging Healthcare Co., Ltd.
uCT 760 System, Computed Tomography X-ray System
| Date | May 8, 2020 |
| Status | Terminated |
| Reason | Two issues were identified with the computed tomography x-ray system including an intermittent issue which may affect image data leading to artifacts; and intermittent scout scanning interruption due to occasional angle signal drift. This may result in the need for rescanning of the patient with the patient receiving an additional dose of radiation and possible use of additional contrast media. |
| Root cause | Software design |
| Action | Customers were sent emails on 05/22/2020 notifying them of the failure modes and the potential safety issues. Customers were informed that If image artifacts occur, it may be necessary for the user to repeat the examination. The rescan of the patient will result in an additional dose and the possible need for additional contrast medium. Customers were also informed that if the scout scanning is unexpectedly interrupted, it may be necessary for the user to repeat the scout scanning, resulting in an additional dose. Customers observing image artifacts were instructed to reboot the system and con |
| Quantity | 5 units |
| Distribution | Distributed to two customers. Both customers located in Houston, Texas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172135 | uCT Computed Tomography X-ray System Shanghai United Imaging Healthcare Co., Ltd., Mar 2, 2018 |