Shanghai United Imaging uMI Panvivo PET/CT system recalled for software visibility issue
What this means
A software problem in the uMI Panvivo PET/CT imaging system can prevent patient images from appearing on the Patient Administration interface when certain functions are enabled and multiple exams are combined into one study. This may require patients to undergo repeat imaging scans.
- If your facility operates the uMI Panvivo system with affected software versions (R002.4.0.1872339), contact Shanghai United Imaging Healthcare for guidance
- Check your system's serial number and software version against the recall notice
- Do not use the Split or Local merge function if your system is affected until updated software is available
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-3286-2026More 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 uCT ATLAS Astound CT system recalled for software visibility issue
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.