The Recall Desk

FDA (Devices) recall action 79134

Philips Medical Systems (Cleveland) Inc recalled 2 products on 2018-03-14

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
2018-03-14
Critical
0
Units
130

Why these products were recalled

Software issues including: Software errors that may result in Extended Field of View check message not displayed when Field of View is set >600 mm for a paused scan; Request for change to automatically turn on the center x/y 0 setting and the disable result rotation setting when turning on the CT simulation Exam Card; Software errors that may result in Tumor LOC allowing POI (Point of Interest) locking when a non-isocenter slice is displayed; Software errors that may result in partial set of images or inability to generate CT images.

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.

1–2 of 2

  • HighFDA (Devices)··2018-03-14

    Philips Recalls Brilliance Big Bore Oncology CT Scanners Due to Software Errors

    Philips Medical Systems is recalling 11 Brilliance Big Bore Oncology CT scanners due to software errors that may affect image generation and display settings.

    Product
    Brilliance Big Bore Oncology CTwith 4.2.0 software version. Model #' 728243 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. The
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    Distribution
    0 states
  • HighFDA (Devices)··2018-03-14

    Philips Brilliance Big Bore CT Software Recall for Image Generation Errors

    Philips is recalling 119 Brilliance Big Bore CT scanners due to software errors that may prevent image generation or display incorrect settings.

    Product
    Brilliance Big Bore Radiology CT with 4.2.0 software version. Model #' 728244 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. Th
    Category
    Distribution
    0 states