FDA-Device2026-07-08Class IIPROCESSING DEFECT
RayCare 2024A SP4 oncology software recalled for beam delivery note data loss risk
What this means
RayCare 2024A SP4 oncology information system has a software issue where beam set delivery notes can lose data if modified at the same time or updated during an active treatment session. Users are not alerted when these changes occur, which could affect treatment record accuracy.
- If your facility uses RayCare 2024A SP4 (software version 8.0.4.60077), contact RayCare support immediately for guidance
- Review recent beam set delivery notes for any simultaneous modifications or updates made during treatment sessions
- Do not modify delivery notes while treatment sessions are in progress until you receive updated instructions
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution.
Affected count
3 units
Manufactured in
Eugeniavagen 18c, N/A, Stockholm, N/A, Sweden
Products
RayCare 2024A SP4. Oncology Information Systems.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2647-2026More Raysearch Laboratories recalls
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