FDA (Devices) recall action 74131
The FDA (Devices) publishes a recall like this one as 6 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 6 pages.
Software issues found in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 products that could affect the performance of the equipment.
Software issues found in v4.1 .3/4.1.5 in the Philips Brilliance iCT/ iCT SP products that could affect the performance of the equipment.
Software issues in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 and Ingenuity CT products that could affect the performance of the equipment.
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 Brilliance 64 CT scanners due to software issues that could affect equipment performance.
Philips is recalling 57 Brilliance iCT SP CT scanners due to software issues in versions 4.1.3 and 4.1.5 that could affect equipment performance.
Philips is recalling Ingenuity Core CT scanners due to software issues in versions v4.1.3, v4.1.4, and v4.1.5 that could affect equipment performance.
Philips is recalling Ingenuity Core128 CT scanners due to software issues in versions 4.1.3, 4.1.4, and 4.1.5 that could affect equipment performance.
Philips Medical Systems is recalling 205 Ingenuity CT units due to software issues in versions 4.1.3, 4.1.4, and 4.1.5 that could affect equipment performance.
Philips Medical Systems is recalling 335 Brilliance iCT units due to software issues in versions v4.1.3 and v4.1.5 that could affect equipment performance.