FDA-Device2018-12-12Class II
Brilliance 10 Slice (Air), Model 728251 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories
Hazard
There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall
Sold states
US Nationwide Distribution
Affected count
N/A
Manufactured in
595 Miner Rd, N/A, Cleveland, OH, United States
Products
Brilliance 10 Slice (Air), Model 728251 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0547-2019Don't want to check this manually?
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