Company: Shanghai United Imaging Healthcare Co., Ltd.
Date of Enforcement Report: 9/25/2026
Class: II
PRODUCT
Computed Tomography X-ray System, Model: uCT 530 with software
Recall Number:
Z-3277-2026
REASON:
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
RECALLING FIRM/MANUFACTURER:
Shanghai United Imaging Healthcare Co., Ltd.
VOLUME:
4
DISTRIBUTION:
US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID, LA, MT, FL, CO, IN, KY, AL, OH, MI, IA, MO, NY, NV, TN, WV, SC, WI, IL, MS, MA, NJ.
