Recall Z-2647-2026 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
RayCare 2024A SP4. Oncology Information Systems.
| Date | Jul 1, 2026 (initiated May 20, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | A Field Safety Notice, Medical Device Correction #175428 dated 6/2/26 was emailed to consignees. The notice advises consignees to ensure clear verbal or procedural communication when updating the beam set delivery note, avoid making changes from any location other than the control room when treatment is ongoing, avoid relying on beam set delivery note for conveying critical information. Additionally, consignees are to ensure planning staff and users are educated of the provided workaround. Consignees are to verify the software version of their units and reply to the emailed notification. A sof |
| Quantity | 3 units |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K242992 | RayCare (2024A SP1) RaySearch Laboratories AB (PUBL), Apr 17, 2025 |