medical Class II Updated 2020-07-15

Shanghai United Imaging Healthcare Co., Ltd. recalls uCT 760 System, Computed Tomography X-ray System

Recalled Product

uCT 760 System, Computed Tomography X-ray System

Hazard / Issue

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.

Issued by

FDA

Distribution: Distributed to two customers. Both customers located in Houston, Texas.
Lot/Code Info: Model uCT 760; Serial Numbers: 600229, 600230, 600232, 600271 with software version R001.11.0.729741-Re-1100, and serial number 600282 with software version R001.11.0.785930-Re-1150.
View official government recall

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