FDA (Devices) recall action 80094
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.
The patient support head holder could contact the back ISO shelter wall during manual or motorized motion through the gantry bore. This may result in a serious injury that would require medical intervention to preclude permanent impairment in certain scenarios.
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 two Brilliance 16 CT systems because the patient support head holder may contact the back ISO shelter wall, posing a risk of serious injury.
Philips is recalling 20 Brilliance 16 P CT systems because the patient support head holder may contact the back ISO shelter wall, posing a risk of serious injury.
Philips is recalling three Brilliance 64 CT systems because the patient support head holder could contact the back ISO shelter wall, posing a risk of serious injury.