Philips Medical Systems (Cleveland) Inc recalls Brilliance 16 Air, 728246 Product Usage: Computed Tomogr
Recalled Product
Brilliance 16 Air, 728246 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. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories
Hazard / Issue
Philips has identified that the compensator within the X-ray tube collimator may fail, resulting in ring or smudge artifacts on images. The firm has identified systems that may be at risk for this failure due to the collimator compensator being past its lifetime expected usage.
Issued by
FDA
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