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Philips North America, LLC recalls Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)008848
Recalled May 13, 2020 · FDA recall Z-1921-2020 · Philips North America
Hazard
The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems. · FDA Class II
Units
19
Sold at
Worldwide distribution including one unit distributed to Iowa.
Description
The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.
Product
Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848
Manufacturer(s)
Philips North America, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →