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FDA-Device2026-01-28Class IIPROCESSING DEFECT

RayStation/RayPlan radiation therapy software recalled for dose calculation error

Raysearch Laboratories
OTHERNationwide distribution

Check RayStation versions 11.0.0–11.0.4 for dose issues

RaySearch Laboratories identified a software bug in RayStation/RayPlan versions 11.0.0 through 11.0.4 (11A, 11A SP1, SP2, SP3) used for radiation therapy treatment planning. When certain regions of interest have no contours but have material overrides or are classified as Bolus, Fixation, or Support types, the software fails to recalculate radiation doses correctly if you modify or remove the material override. This could result in outdated or incorrect dose calculations being used for treatment planning.

  • If you use RayStation versions 11.0.0–11.0.4, verify whether you are affected by contacting RaySearch Laboratories or your institution's radiation oncology team.
  • Review any treatment plans created with these software versions, especially those involving material overrides or bolus/fixation/support regions.
  • Upgrade to a patched software version when available from RaySearch Laboratories.
  • Consult your institution's physicist or RaySearch support for guidance on validating affected treatment plans.
Hazard

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.

Sold states
Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS
Affected count
10 units
Manufactured in
Eugeniavagen 18c, Stockholm, Sweden
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1103-2026

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