The Recall Desk

FDA (Devices) recall action 74427

Philips Medical Systems (Cleveland) Inc recalled 3 products on 2016-07-06

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
2016-07-06
Critical
0
Units
131

Why these products were recalled

Philips Healthcare received reports from the field that certain Ingenuity Core128 systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images. A patient rescan may be required if the images cannot be used for interpretation due to the swirl-like artifact.

Philips Healthcare received reports from the field that certain Ingenuity Core systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images. A patient rescan may be required if the images cannot be used for interpretation due to the swirl-like artifact.

Philips Healthcare received reports from the field that certain Brilliance 64 systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images. A patient rescan may be required if the images cannot be used for interpretation due to the swirl-like artifact.

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.

States named across these recalls

1–3 of 3

  • ModerateFDA (Devices)··2016-07-06

    Philips Ingenuity Core 128 CT Scanner Recalled for Image Artifacts

    Philips is recalling 19 Ingenuity Core 128 CT scanners because software version 3.5.4 may cause swirl-like artifacts on images, potentially requiring patient rescans.

    Product
    Ingenuity Core 128-Computed Tomography X-ray system Product Usage: The Ingenuity Core 128 scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different…
    Category
    Distribution
    8 states
  • ModerateFDA (Devices)··2016-07-06

    Philips Ingenuity Core CT Systems Recalled for Image Artifacts

    Philips is recalling 18 Ingenuity Core CT systems because software version 3.5.4 may cause swirl-like artifacts on images, potentially requiring patient rescans.

    Product
    Ingenuity Core-Computed Tomography X-ray system Product Usage: The Ingenuity Core scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles…
    Category
    Distribution
    8 states
  • ModerateFDA (Devices)··2016-07-06

    Philips Brilliance 64 CT Scanner Recall for Image Artifacts

    Philips is recalling 94 Brilliance 64 CT scanners due to intermittent swirl-like ring artifacts on images, which may require patient rescans.

    Product
    Brilliance 64, Computed Tomography X-ray system Product Usage: The Brilliance CT 64 scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles…
    Category
    Distribution
    8 states