FDA-Device2019-04-24Class II
Brilliance iCT, 728306 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. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories
Philips Medical Systems (Cleveland) Inc
Hazard
Philips has identified that the compensator within the X-ray tube collimator may fail, resulting in ring or smudge artifacts on images. The firm has identified systems that may be at risk for this failure due to the collimator compensator being past its lifetime expected usage.
Sold states
Distributed only to China and UK.
Affected count
2
Manufactured in
595 Miner Rd, N/A, Cleveland, OH, United States
Products
Brilliance iCT, 728306 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. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1144-2019Don't want to check this manually?
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