FDA-Device2018-01-24Class II
Brilliance iCT Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Philips Medical Systems (Cleveland) Inc
Hazard
Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose, which may have a potential for harm.
Sold states
Worldwide Distribution -- US, Argentina, China, Republic of Korea, Russian Federation, Slovakia, Turkey, and United Kingdom. 4 in US, (1 military), 14 foreign accounts
Affected count
13
Manufactured in
595 Miner Rd, N/A, Cleveland, OH, United States
Products
Brilliance iCT Intended to produce images of the head and 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-0388-2018Don't want to check this manually?
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