FDA-Device2026-01-28Class IIPROCESSING DEFECT

RayStation/RayPlan 10B radiation therapy software recalled for dose calculation error

OTHERNationwide distribution

Check RayStation/RayPlan 10B for dose calculation issues

RaySearch Laboratories' RayStation/RayPlan version 10B has a software issue that can prevent proper recalculation of radiation therapy doses when certain regions are modified. This affects specific treatment planning scenarios where regions have no contours but have material overrides or are classified as Bolus, Fixation, or Support types. Stale dose calculations may be used instead of updated ones.

  • Review your RayStation/RayPlan software version; this affects version 10B only
  • Contact RaySearch Laboratories or your vendor for a software update or patch
  • If using affected features, verify dose calculations are recalculated after modifying regions of interest
  • Check the provided distribution list to confirm if your facility received affected software
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
0
Manufactured in
Eugeniavagen 18c, Stockholm, Sweden
Products
RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatment Planning System

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1102-2026

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