FDA (Devices) recall action 87419
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.
The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.
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.
Canon Medical System is recalling 272 INFX-8000F systems because the x-ray field may shift at certain angles.
Canon Medical System is recalling 272 INFX-8000C C-arm systems nationwide because the x-ray irradiation field may shift relative to the displayed image at certain angles.
Canon Medical System is recalling 272 INFX-8000V systems because the x-ray field may shift relative to the displayed image at certain angles.