medical Class II Updated 2019-04-24

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

Distribution: Distributed only to China and UK.
Lot/Code Info: 6143 5701 50069 6232 6563 50007 5928 3466 6301 6328 50048 6145 5560 6324 5908 6520 5924 5496 6507 5944 6351 6149 6562
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