Shanghai United Imaging uMI 550 PET/CT system recalled for software display issue
What this means
Certain Shanghai United Imaging uMI 550 PET/CT systems have a software problem that can hide patient images from the display when specific functions are enabled and multiple exams are merged. This may require patients to undergo repeat scans.
- Contact your equipment vendor or Shanghai United Imaging for a software update
- Check your system serial number and software version against the affected list
- Verify images are visible before proceeding with patient scans
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-3283-2026More 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 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
- FDA-Device2026-10-07Shanghai United Imaging uCT ATLAS Astound CT system recalled for software visibility issue
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