The Recall Desk

FDA (Devices) recall action 76683

Philips Medical Systems (Cleveland) Inc recalled 2 products on 2017-03-29

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2017-03-29
Critical
0
Units
78

Why these products were recalled

Philips identified a 4D CT pulmonary phase issue on Brilliance BigBore Oncology/Radiology CT with 4.2.0 software version through customer complaints. When the user performs a retrospective respiratory gated 4D CT scan with the Bellows pulmonary gating device, the CT images might be reconstructed at a single phase, while the annotations on the images incorrectly indicate that the reconstruction is from the requested specific phases (0% to 90%).

When the user performs a retrospective respiratory gated 4D CT scan with the Bellows pulmonary gating device, the CT images might be reconstructed at a single phase, while the annotations on the images incorrectly indicate that the reconstruction is from the requested specific phases (0% to 90%).

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

1–2 of 2

  • ModerateFDA (Devices)··2017-03-29

    Philips Recalls Brilliance BigBore CT Scanners Due to Image Reconstruction Error

    Philips is recalling 67 Brilliance BigBore CT scanners because 4D CT images may be reconstructed at a single phase while incorrectly labeled as specific phases.

    Product
    Brilliance BigBore Radiology CT - 728244 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. These devices may include signal analysts and display equ
    Category
    Distribution
    22 states
  • ModerateFDA (Devices)··2017-03-29

    Philips CT Scanner Recall for Incorrect 4D CT Image Phase Annotations

    Philips is recalling 11 Brilliance BigBore Oncology CT scanners because retrospective 4D CT scans may display incorrect phase annotations.

    Product
    Brilliance BigBore Oncology CT - 728243 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. These devices may include signal analysts and display equi
    Category
    Distribution
    22 states