RAYSEARCH LABORATORIES AB — Class II: RayCare 2024A SP1. Oncology Information Systems.
RaySearch Laboratories AB has initiated a Class II recall for its RayCare 2024A SP1 oncology information system due to potential data loss issues occurring when beam set delivery notes are modified simultaneously or updated during treatment sessions without user notification.
This recall affects clinical facilities using RayCare 2024A SP1 and internal IT/Regulatory teams responsible for managing oncology information system software updates and data integrity.
The lack of notification during note updates or simultaneous modifications suggests a concurrency control failure in the software. This presents a risk to data integrity within a clinical oncology workflow, where accurate delivery notes are critical for treatment verification and patient safety. Regulatory professionals should note the ongoing status of the recall and the technical nature of the software defect.
Quality teams should verify if local installations of RayCare 2024A SP1 are in use and check for manufacturer-issued patches or updates regarding beam set delivery notes. Clinical users should be instructed to avoid simultaneous modifications of these notes until a fix is confirmed to prevent potential data loss.
Class II. Reason: 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.. Product: RayCare 2024A SP1. Oncology Information Systems.. Firm: RAYSEARCH LABORATORIES AB (Stockholm N/A Sweden). Status: Ongoing.
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