FDA-Device2026-07-08Class IIPROCESSING DEFECT
RayCare 2024A SP1 oncology software recalled for potential data loss in beam set delivery notes
What this means
RayCare 2024A SP1 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 may not be notified when these changes occur, potentially affecting treatment records.
- Contact RayCare support or your system administrator immediately if your facility uses RayCare 2024A SP1 version 8.0.1.60193
- Do not simultaneously edit beam set delivery notes or update notes during ongoing treatment sessions until you receive guidance
- Check your treatment records and beam set delivery notes for any missing or unexpected changes
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 SP1. Oncology Information Systems.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2646-2026More Raysearch Laboratories recalls
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.