FDA-Device2020-05-13Class II
Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848
Philips North America, LLC
Hazard
The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.
Sold states
Worldwide distribution including one unit distributed to Iowa.
Affected count
19
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1921-2020Don't want to check this manually?
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