FDA (Devices) recall action 83295
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.
Failure to meet the requirement of the performance standard for cabinet x-ray systems (21 CFR 1020.40) for a door interlock that causes physical disconnection of the power supply using only the movement of the door.
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.
Comet Technologies is recalling 93 YXLON Cougar Cabinet X-Ray Systems because the door interlocks fail to meet federal performance standards for power disconnection.
Comet Technologies is recalling 77 YXLON Cheetah cabinet X-Ray systems because the door interlock fails to meet federal performance standards for power disconnection.