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FDA-Device2026-01-28Class IIPROCESSING DEFECT

RaySearch RayStation radiation therapy software recalled for dose calculation error

Raysearch Laboratories
OTHERNationwide distribution

Contact RaySearch about RayStation software update

RaySearch RayStation/RayPlan radiation therapy planning software (versions 11B through 11B SPT1) has a bug that prevents dose calculations from updating correctly when changes are made to certain regions of interest with material overrides or specific geometry types. This could result in treatment plans using outdated radiation dose calculations.

  • If your facility uses affected RayStation software versions, contact RaySearch Laboratories immediately
  • Do not rely on dose calculations for regions of interest without contours until you receive a software update
  • Verify your software version and check the distribution list to confirm if your facility is affected
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
22 units
Manufactured in
Eugeniavagen 18c, Stockholm, Sweden
Products
RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software Version: RayStation 11B, RayStation 11B SP1, RayStation 11B SP2, RayStation 11B SP3, RayStation 11B SPT1. Radiation Therapy Treatment Planning System

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1104-2026

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