FDA (Devices) recall action 78852
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.
Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose, which may have a potential for harm.
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 one Brilliance 64 CT scanner because certain fasteners may not be torqued to specification, posing a potential risk of harm if parts become loose.
Philips is recalling three Ingenuity Core 128 CT scanners because certain fasteners may not have been torqued to specification, posing a potential risk of harm if parts become loose during use.
Philips is recalling one Ingenuity Core CT scanner because certain fasteners cannot be confirmed to be torqued to specification, posing a potential risk of harm if parts become loose during use.
Philips is recalling 13 Brilliance iCT scanners because certain fasteners may not have been torqued to specification, posing a potential risk of harm if parts become loose during use.