FDA (Devices) recall action 89915
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.
Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step.
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.
Siemens CT scanner software upgrade may cause incorrect laser offset coordinates to display during patient positioning. No injuries reported.
Siemens CT scanner software upgrade may display incorrect laser offset coordinates during patient marking. This defect affects 15 systems in the US across multiple states.
Siemens CT scanner imaging software upgraded to version VB60 may display incorrect laser offset coordinates during patient marking. Fourteen units are affected in the United States.
Siemens syngo.via RT imaging software upgraded to VB60 automatically modifies laser configuration, potentially displaying incorrect laser offset coordinates during radiation therapy patient marking.