FDA (Devices) recall action 72684
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.
Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion license key could not access the basic axial perfusion feature after upgrading to software version 4.1.2.
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 51 Brilliance iCT CT systems because the perfusion scan feature may be unavailable on specific software versions.
Philips is recalling 31 Ingenuity CT systems because the perfusion scan feature may be unavailable on specific software versions.
Philips is recalling 177 Ingenuity Core 128 CT systems because the perfusion scan feature may be unavailable on specific software versions.
Philips is recalling 12 Brilliance iCT SP CT systems because the perfusion scan feature may be unavailable on specific software versions.
Philips Medical Systems is recalling 135 Ingenuity Core CT systems because a software upgrade may have restricted access to the basic axial perfusion feature for some users.
Philips is recalling 30 Brilliance 64 CT systems because the perfusion scan feature may be unavailable on specific software versions.