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