FDA (Devices) recall action 91806
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.
The agency’s own wording, quoted from the enforcement report.
Philips recalls SmartPerfusion cardiac imaging software for technical issues in signal generation and processing that can produce inaccurate diagnostic output.
Philips is recalling 2D Perfusion diagnostic imaging software due to signal processing errors that can produce inaccurate presentations, potentially affecting clinical decisions.