Company: Shanghai United Imaging Healthcare Co., Ltd.
Date of Enforcement Report: 8/19/2020
Class II
PRODUCT
uEXPLORER PET/CT Diagnostic Imaging System – Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.
Recall Number: Z-2799-2020
REASON
Issues were identified with the PET/CT diagnostic imaging systems including: a potential intermittent issue leading to image artifacts; potential intermittent scout scanning interruption; a problem with one of the service functions which may cause false marking of a bad channel resulting in ring artifacts; and the possibility of unevenness of the metal edge which overlaps the mylar strip in the gantry which may create a sharp edge. These issues may require re-scanning of the patient resulting in additional radiation exposure, and possible abrasion to the patient’s arm from a sharp metal edge.
RECALLING FIRM/MANUFACTURER
Shanghai United Imaging Healthcare Co., Ltd. on 7/16/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1 unit distributed to Texas
DISTRIBUTION
U.S. Nationwide