Recall Z-2641-2020 ยท JAK System, X-Ray, Tomography, Computed
Shanghai United Imaging Healthcare Co., Ltd.
Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 Intended use The uCT Computed Tomography X-ray System uCT 530/uCT 550 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck and vascular).
| Date | Jul 20, 2020 (initiated May 23, 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 | On 05/23/2020, Customer Notification Letters dated 5/22/2020 were emailed to customers. Customers were asked to do the following: For safety issue 1: If you observe image artifacts, please reboot the system and continue the reconstruction. If the image artifacts persist, please contact the recalling firm's service support team or call the Customer Contact Center at (855) 221-1552 (toll free) or (832) 699-2799 (direct). For safety issue 2: If the scout scanning is interrupted, try repeating the scout scanning. If problem persists, please contact the recalling firm's service support team or cal |
| Quantity | 3 |
| Distribution | US Distribution to state of: TX |
| 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 |