FDA (Devices) recall action 85513
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 bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.
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 North America, LLC is recalling 19 Brilliance iCT Computed Tomography X-Ray Systems because a bolt affixing the cooling unit to the rotor was not tightened to specification.
Philips is recalling two Brilliance iCT SP CT scanners because a cooling unit bolt was not tightened to specification.
Philips is recalling two Brilliance IQon Spectral CT systems because a bolt on the cooling unit was not tightened to specification.