FDA-Device2020-05-13Class II
Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311
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
2
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1922-2020Don't want to check this manually?
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