The Recall Desk

FDA (Devices) recall action 80640

Philips Medical Systems (Cleveland) Inc recalled 3 products on 2019-04-24

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2019-04-24
Critical
0
Units
39

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • ModerateFDA (Devices)··2019-04-24

    Philips Brilliance iCT CT Scanners Recalled for Collimator Compensator Failure

    Philips is recalling two Brilliance iCT CT scanners because a component may fail, causing image artifacts. The devices were distributed only to China and the UK.

    Product
    Brilliance iCT, 728306 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…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2019-04-24

    Philips Brilliance 64 CT Systems Recalled for Image Artifacts

    Philips is recalling 14 Brilliance 64 CT systems because a component may fail, causing ring or smudge artifacts on images.

    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…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2019-04-24

    Philips Brilliance 16 Air CT Systems Recalled for Collimator Defect

    Philips is recalling 23 Brilliance 16 Air CT systems because a collimator component may fail, causing image artifacts.

    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…
    Category
    Distribution
    0 states