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Recall Observatory FDA recall evidence

Device 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

Z-1143-2019

July 03, 2018

Class II

Product summary

Firm
Philips Medical Systems (Cleveland) Inc
Event
Event 80640
Status
Terminated
Classification
Class II
Quantity
14
Official record key
device-enforcement:Z-1143-2019

Official wording

Reason: 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.

Code information: 10011 95620 10436 95486 95391 95838 95807 95621 10521 10255 10006 10715 10275 10616

Distribution pattern: Distributed only to China and UK.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.