FDA-Device2025-10-29Class II
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 780 MD, Rx Only
UIH Technologies LLC
Hazard
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Sold states
US: OUS:
Affected count
3 units
Manufactured in
9380 Kirby Dr, Houston, TX, United States
Products
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 780 MD, Rx Only
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0224-2026Don't want to check this manually?
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