medical Class II Updated 2020-07-08

Shanghai United Imaging Healthcare Co., Ltd. recalls uCT 530 Computed Tomography X-Ray System

Recalled Product

uCT 530 Computed Tomography X-Ray System


Hazard / Issue

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.

Issued by

FDA

Distribution: Distributed to Texas.
Lot/Code Info: Units with software version no. R001.11.0.729741-Re-1100 including the following: Serial number/GTIN: 300162 (GTIN: 6971576831012); 300163 (GTIN: 6971576831012); 300174 (GTIN: 6971576831012); and 300176 (GTIN: 6971576831012).
View official government recall

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