FDA Device recall Z-2522-2020
uCT 760 System, Computed Tomography X-ray System
- FDA Device
- Class II
- terminated
- Published 2020-07-15
On 2020-07-15 the FDA classified a Class II recall of uCT 760 System, Computed Tomography X-ray System by Shanghai United Imaging Healthcare, citing 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 scann….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2522-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-05-08 |
| Published | 2020-07-15 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Shanghai United Imaging Healthcare |
| Distribution | TX |
Product
uCT 760 System, Computed Tomography X-ray System
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.
Identifiers
| code_info | Model uCT 760; Serial Numbers: 600229, 600230, 600232, 600271 with software version R001.11.0.729741-Re-1100, and seria…Model uCT 760; Serial Numbers: 600229, 600230, 600232, 600271 with software version R001.11.0.729741-Re-1100, and serial number 600282 with software version R001.11.0.785930-Re-1150. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2522-2020%22
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