Shanghai United Imaging uCT 550 CT scanner software issue may hide patient images
What this means
A software problem in certain uCT 550 computed tomography systems can prevent patient images from appearing in the Patient Administration interface when the Split or Local function is enabled and multiple exams are combined into one study. This may require patients to undergo repeat scans.
- If you operate an affected uCT 550 system, contact Shanghai United Imaging Healthcare for a software update
- Review recent merged studies to verify images are visible before clinical use
- Contact the manufacturer for a list of affected serial numbers and software versions
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-3278-2026More 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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