Skip to content
Recall Observatory FDA recall evidence

Device 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

Z-1142-2019

July 03, 2018

Class II

Product summary

Firm
Philips Medical Systems (Cleveland) Inc
Event
Event 80640
Status
Terminated
Classification
Class II
Quantity
23
Official record key
device-enforcement:Z-1142-2019

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: 6143 5701 50069 6232 6563 50007 5928 3466 6301 6328 50048 6145 5560 6324 5908 6520 5924 5496 6507 5944 6351 6149 6562

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.