FDA Device recall Z-2472-2020
uCT 530 Computed Tomography X-Ray System
- FDA Device
- Class II
- ongoing
- Published 2020-07-08
On 2020-07-08 the FDA classified a Class II recall of uCT 530 Computed Tomography X-Ray System by Shanghai United Imaging Healthcare, citing 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 p….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2472-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-05-08 |
| Published | 2020-07-08 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Shanghai United Imaging Healthcare |
| Distribution | TX |
Product
uCT 530 Computed Tomography X-Ray System
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.
Identifiers
| code_info | Units with software version no. R001.11.0.729741-Re-1100 including the following: Serial number/GTIN: 300162 (GTIN: 69…Units with software version no. R001.11.0.729741-Re-1100 including the following: Serial number/GTIN: 300162 (GTIN: 6971576831012); 300163 (GTIN: 6971576831012); 300174 (GTIN: 6971576831012); and 300176 (GTIN: 6971576831012). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2472-2020%22
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