FDA (Devices) recall action 71227
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.
A head holder released for use with other CT systems but not yet qualified for use on the Ingenuity Core, which was shipped with this system.
A head holder released for use with other CT systems but not yet qualified for use on the Ingenuity Core 128, which was shipped with this system.
A head holder released for use with other CT systems but not yet qualified for use on the Ingenuity CT, which was shipped with this system.
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 79 head holders shipped with Ingenuity Core CT systems because they were not qualified for use on this specific model.
Philips Medical Systems is recalling 55 head holders shipped with Ingenuity Core 128 CT systems because they were not qualified for use on this specific model.
Philips Medical Systems is recalling 66 head holders shipped with Ingenuity CT systems because they were not qualified for use on this specific model.