FDA (Devices) recall action 74083
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.
The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image.
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 Healthcare is recalling 160 DigitalDiagnost stationary X-ray systems because the detector may incorrectly signal readiness, resulting in failed image acquisition.
Philips Healthcare is recalling five DuraDiagnost stationary X-ray systems because the detector may incorrectly signal readiness, causing failed image acquisitions.