FDA (Devices) recall action 71926
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.
During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan.
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 seven Brilliance 64 CT systems because software may set the scan length differently than planned.
The FDA is recalling 105 Philips Ingenuity CT scanners because software errors can cause the scan length to differ from the user's plan.
Philips is recalling 105 Ingenuity Core 128 CT scanners because software may unexpectedly change the scan length during specific protocols.
Philips is recalling 105 Ingenuity Core CT scanners because software may set the scan length differently than planned during specific protocols.