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Shanghai United Imaging Healthcare Co., Ltd. recalls uCT 530 Computed Tomography X-Ray System
Recalled July 8, 2020 · FDA recall Z-2472-2020 · Shanghai United Imaging Healthcare
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. · FDA Class II
Units
4 units
Sold at
Distributed to Texas.
Description
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.
Product
uCT 530 Computed Tomography X-Ray System
Manufacturer(s)
Shanghai United Imaging Healthcare Co., Ltd.
Made in
China
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →