← All recalls
Medical Device

Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with software

Recall date: 2026-10-07 · Source: FDA_DEVICE
Brand / Firm
Shanghai United Imaging Healthcare Co., Ltd.
Product
Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with software
Reason for recall
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.
Units affected
34
Description
Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with software
View official recall notice →