FDA-Device2020-07-08Class II
uCT 530 Computed Tomography X-Ray System
Shanghai United Imaging Healthcare Co., Ltd.
Hazard
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.
Sold states
Distributed to Texas.
Affected count
4 units
Manufactured in
No. 2258 Chengbei Rd, Jiading Ind., N/A, Shanghai, N/A, China
Products
uCT 530 Computed Tomography X-Ray System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2472-2020Don't want to check this manually?
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