FDA (Devices) recall action 72282
The FDA (Devices) publishes a recall like this one as 6 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 6 pages.
The firm discovered Ring/Dot artifact due to X-ray measurement error.
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 Medical Systems is recalling 109 Ingenuity Core 128 CT systems due to X-ray measurement errors causing image artifacts.
Philips is recalling 36 Ingenuity Core CT systems worldwide due to an X-ray measurement error that causes Ring/Dot artifacts in images.
Philips Medical Systems is recalling 323 Brilliance 16-Slice CT systems worldwide due to X-ray measurement errors causing Ring/Dot artifacts.
Philips Medical Systems is recalling 268 Brilliance Big Bore CT systems worldwide due to X-ray measurement errors causing image artifacts.
Philips Medical Systems is recalling 108 Brilliance 64 CT systems worldwide due to an X-ray measurement error that causes Ring/Dot artifacts.
Philips Medical Systems is recalling 67 Ingenuity Flex CT systems worldwide due to an X-ray measurement error that causes Ring/Dot artifacts in images.