medical Class II Updated 2019-04-24

Philips Medical Systems (Cleveland) Inc recalls Brilliance 64, 728231 Product Usage: Computed Tomography

Recalled Product

Brilliance 64, 728231 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: 10011 95620 10436 95486 95391 95838 95807 95621 10521 10255 10006 10715 10275 10616
View official government recall

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