Shanghai United Imaging uCT 780 CT scanner recalled for software visibility issue
What this means
Certain uCT 780 computed tomography systems have a software problem that can prevent patient images from appearing on the Patient Administration interface when the Split or Local function is enabled and multiple exams are merged into one study. This may require patients to undergo repeat scans.
- Contact Shanghai United Imaging Healthcare Co., Ltd. if your facility operates an affected uCT 780 system
- Check your system's serial number and software version against the recall notice
- Do not merge multiple RIS exams into a single study using Split or Local functions until your system is updated
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3280-2026More United Imaging recalls
- FDA-Device2026-10-07Shanghai United Imaging uMI 780 PET/CT system recalled for software visibility issue
- FDA-Device2026-10-07Shanghai United Imaging uMI 550 PET/CT system recalled for software display issue
- FDA-Device2026-10-07Shanghai United Imaging uMI Panorama GS PET/CT system recalled for software visibility issue
- FDA-Device2026-10-07Shanghai United Imaging uCT 760 CT system recalled for software visibility issue
- FDA-Device2026-10-07Shanghai United Imaging uMI Panvivo PET/CT system recalled for software visibility issue
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