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Philips Medical Systems (Cleveland) Inc recalls Brilliance iCT Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the b
Recalled January 18, 2017 · FDA recall Z-1004-2017 · Philips Medical Systems (Cleveland)
Hazard
Failure to correctly document the installation of four M12 Bolts into the system rotor. · FDA Class II
Units
1
Sold at
The one system was distributed in Canada. There were no government or US distribution.
Description
Failure to correctly document the installation of four M12 Bolts into the system rotor.
Product
Brilliance iCT Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories
Manufacturer(s)
Philips Medical Systems (Cleveland) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →