FDA-Device2018-04-25Class II
Brilliance 64 with 4.1.7 XX026 software version model number 728231 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 analysis and display equipment, patient and equipment supports, components, and accessories
Philips Medical Systems (Cleveland) Inc
Hazard
Surview scan with tube current lower than 30 mA is unable to be initialized.
Sold states
Worldwide Distribution - US Nationwide in the states of GA, VA, MI, AZ, and the countries of Canada, Switzerland
Affected count
291
Manufactured in
595 Miner Rd, Cleveland, OH, United States
Products
Brilliance 64 with 4.1.7 XX026 software version model number 728231 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 analysis and display equipment, patient and equipment supports, components, and accessories
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1396-2018Don't want to check this manually?
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