Recall Z-1103-2026 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStation 11A SP1, RayStation 11A SP2, RayStation 11A SP3. Radiation Therapy Treatment Planning System
| Date | Jan 16, 2026 (initiated Nov 28, 2025) |
| Status | Open, Classified |
| Reason | Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended. |
| Root cause | Under Investigation by firm |
| Action | RaySearch Laboratories notified consignees via email on about 12/05/2025. Consignees were instructed to follow the outlined steps in the notification letter when adding geometry to an empty ROI with MO or type Bolus, Fixation or Support, educate planning staff and all users about the workaround, inspect units and identify all installed units with the affected software version numbers, and confirm receipt and understanding of the customer notification by responding to the notification email. The issue will be resolved in the next version of RayStation, scheduled for market release in Decembe |
| Quantity | 10 units |
| Distribution | Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211867 | RayStation 11.0 RaySearch Laboratories AB (PUBL), Sep 8, 2021 |