FDA (Devices) recall action 92202
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down
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 Incisive CT Plus imaging systems due to a metal mounting box that may separate from the rotating scanner and potentially injure users.
A metal mounting box in the Incisive CT scanner may become expelled, potentially injuring users or causing the system to shut down. Philips is recalling 20 affected units distributed internationally.
A metal mounting box in the Incisive CT Power scanner may detach and potentially injure operators or cause system failure. Philips is recalling 53 affected units distributed worldwide.
The metal mounting box on the rotating scanner of the Incisive CT system may become detached and contact other components, potentially injuring users or causing system shutdown.