FDA-Device2018-01-31Class II
Brilliance iCT - Model 728306 Computed Tomography X-ray systems
Philips Medical Systems (Cleveland) Inc
Hazard
Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error message, length of acquisition, image volume and other functions.
Sold states
Worldwide distribution, including US nationwide.
Affected count
559 total
Manufactured in
595 Miner Rd, N/A, Cleveland, OH, United States
Products
Brilliance iCT - Model 728306 Computed Tomography X-ray systems
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0403-2018Don't want to check this manually?
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