FDA (Devices) recall action 99141
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.
Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.
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.
RayCare 2024A SP1 oncology software may lose data if beam set delivery notes are modified simultaneously or updated during treatment sessions, with users not notified of changes.
RayCare 2024A SP4 oncology information system may lose data or fail to notify users when beam set delivery notes are modified simultaneously or updated during treatment sessions.