Shanghai United Imaging uMI Panorama GS PET/CT system recalled for software visibility issue
What this means
A software problem in the uMI Panorama GS PET/CT imaging system can prevent patient images from appearing on the Patient Administration interface when certain functions are enabled and multiple exams are merged. This may require patients to undergo rescans to obtain the needed images.
- If your facility uses this system, contact Shanghai United Imaging for technical support and guidance
- Report any instances where patient images were not visible to your equipment vendor
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-3285-2026More 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 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
- FDA-Device2026-10-07Shanghai United Imaging uCT ATLAS Astound CT system recalled for software visibility issue
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