FDA (Devices) recall action 92230
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.
There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray machine may break which causes the detector to move until it is stopped by the movement end-stop.
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.
FDA recalls the Intelli-C X-Ray machine's left side suspended tabletop model due to potential drive shaft failure in the detector lift mechanism, which could cause uncontrolled detector movement.
The FDA is recalling 32 X-ray detector units due to a potential drive shaft failure that could cause uncontrolled detector movement. Affected units are distributed in 10 US states.