FDA (Devices) recall action 75516
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 product label does not include the correct current rating.
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 is recalling 15 Ingenuity Core 128 CT scanners because the product labels do not include the correct current rating.
Philips is recalling 27 Ingenuity CT systems because the product labels do not include the correct current rating.
Philips Medical Systems is recalling 67 Brilliance iCT Computed Tomography X-ray systems because the product labels do not include the correct current rating.
Philips is recalling two Ingenuity Core CT systems because the product labels do not include the correct current rating.
Philips is recalling three Brilliance ICT SP CT systems because the product labels do not include the correct current rating.
Philips Medical Systems is recalling three IQon Spectral CT systems because the product labels do not include the correct current rating.