FDA (Devices) recall action 93819
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.
While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there will be differences in image content, image format and image size.
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.
Philips CombiDiagnost R90 fluoroscopy systems may display a previous patient's images during radiography examination, potentially showing different image content, format, and size that could affect imaging accuracy.
The Philips CombiDiagnost R90 fluoroscopy device may display a previous patient's radiography images during an examination, risking privacy violation and diagnostic errors in 86 affected units.