FDA-Device2016-07-06Class II
Brilliance 64, Computed Tomography X-ray system Product Usage: The Brilliance CT 64 scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes
Philips Medical Systems (Cleveland) Inc
Hazard
Philips Healthcare received reports from the field that certain Brilliance 64 systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images. A patient rescan may be required if the images cannot be used for interpretation due to the swirl-like artifact.
Sold states
US Nationwide Distribution in the states of CA, FL, ID, KS, MI, NY,OH,TX
Affected count
94
Manufactured in
595 Miner Rd, Cleveland, OH, United States
Products
Brilliance 64, Computed Tomography X-ray system Product Usage: The Brilliance CT 64 scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2116-2016Don't want to check this manually?
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