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Shanghai United Imaging Healthcare Co., Ltd. recalls uCT 760 System, Computed Tomography X-ray System
Recalled July 15, 2020 · FDA recall Z-2522-2020 · Shanghai United Imaging Healthcare
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. · FDA Class II
Units
5 units
Sold at
Distributed to two customers. Both customers located in Houston, Texas.
Description
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.
Product
uCT 760 System, 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 →