FDA-Device2025-10-29Class II
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 550 MD, Rx Only
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
22 units
Manufactured in
9380 Kirby Dr, Houston, TX, United States
Products
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 550 MD, Rx Only
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0218-2026Want us to check the next one for you?
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