FDA-Device2017-01-18Class II
Brilliance iCT 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
Philips Medical Systems (Cleveland) Inc
Hazard
Failure to correctly document the installation of four M12 Bolts into the system rotor.
Sold states
The one system was distributed in Canada. There were no government or US distribution.
Affected count
1
Manufactured in
595 Miner Rd, Cleveland, OH, United States
Products
Brilliance iCT 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-1004-2017Don't want to check this manually?
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