medical Class II Updated 2020-05-13

Philips North America, LLC recalls Philips Brilliance iCT Computed Tomography X-Ray System; Mod

Recalled Product

Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848


Hazard / Issue

The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.

Issued by

FDA

Distribution: Worldwide distribution including one unit distributed to Iowa.
Lot/Code Info: Serial #s 100193, 100408, 100457, 100783, 100356, 100113, 100380, 100318, 100848, 100112, 100742, 100447, 100685, 100375, 100449, 100659, 100158, 100398 Additional serial number as of 5/22/20: 100117
View official government recall

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