Shanghai United Imaging Healthcare Co., Ltd.: Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S with software
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- Company / brand
- Shanghai United Imaging Healthcare Co., Ltd.
- Product
- Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S with software
- Reason / hazard
- 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID, LA, MT, FL, CO, IN, KY, AL, OH, MI, IA, MO, NY, NV, TN, WV, SC, WI, IL, MS, MA, NJ.
- Recall initiated
- 2026-08-11
- Code info
- UDI-DI: 06971576832255. Serial Number/Software: 11MI510005/R003.2.0.1872339, 20MI510001/R003.2.0.1872339, 20MI510002/R003.2.0.1872339, 20MI510003/R003.2.0.1872339, 20MI510004/R003.2.0.1872339, 20MI510005/R003.2.0.1872339
- Product quantity
- 6
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Shanghai
- Country
- China
- Event id
- 99731
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