FDA-Device2020-07-15Class II
uCT 760 System, Computed Tomography X-ray System
Shanghai United Imaging Healthcare Co., Ltd.
Hazard
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.
Sold states
Distributed to two customers. Both customers located in Houston, Texas.
Affected count
5 units
Manufactured in
No. 2258 Chengbei Rd, Jiading Ind., Shanghai, China
Products
uCT 760 System, Computed Tomography X-ray System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2522-2020Don't want to check this manually?
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