Recall Z-2472-2020 ยท JAK System, X-Ray, Tomography, Computed
Shanghai United Imaging Healthcare Co., Ltd.
uCT 530 Computed Tomography X-Ray System
| Date | May 8, 2020 |
| Status | Open, Classified |
| Reason | Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent scout scanning interruption due to occasional angle signal drift.. If these problems occur, it may be necessary to rescan the patient resulting in an additional dose of radiation and the possible need for additional contrast medium. |
| Root cause | Software design |
| Action | The firm sent letters to their customers by email on 5-22-2020. The letter informs customers of the two potential safety issues with the device, and notes that these problems may cause image artifacts and scanning workflow interruptions. Risks to patient health are noted to include the possible need to rescan the patient resulting in an additional radiation dose and the possible need for additional contrast medium. Customers were informed that United Imaging has released a field update for the uCT 530 to address the issues. If customers observe image artifacts, they are requested to reboot the |
| Quantity | 4 units |
| Distribution | Distributed to Texas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181414 | uCT 530, uCT 550 Shanghai United Imaging Healthcare Co., Ltd., Aug 14, 2018 |