Recall – X-ray system service function results in false markings

Company: Shanghai United Imaging Healthcare Co., Ltd.
Date of Enforcement Report: 7/8/2020
Class II

PRODUCT

uCT 530 Computed Tomography X-Ray System

Recall Number: Z-2472-2020

REASON

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.

RECALLING FIRM/MANUFACTURER

Shanghai United Imaging Healthcare Co., Ltd. on 5/8/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

4 units

DISTRIBUTION

U.S. Nationwide

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.