FDA (Devices) recall action 98248
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.
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.
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 3 units of the Spectral CT 7500 on Rails because fasteners attaching the rotor to the gantry bearing may not be torqued to specification.
Philips is recalling 47 units of the Brilliance iCT because fasteners attaching the rotor to the gantry bearing may not be torqued to specification.
Philips is recalling 283 Spectral CT units because fasteners attaching the rotor to the gantry bearing may not be torqued to specification.
Philips is recalling 52 IQon Spectral CT units because fasteners attaching the rotor to the gantry bearing may not be torqued to specification.