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FDA-Device2026-01-28Class IIPROCESSING DEFECT

RayStation radiation therapy planning software recalled for dose calculation error

Raysearch Laboratories
OTHERNationwide distribution

Update RayStation treatment planning software

RayStation versions 17.0.0 and 17.0.1 have a software error that prevents dose calculations from updating properly when certain regions of interest are modified. This can occur when regions have no contours but include material overrides or are marked as Bolus, Fixation, or Support types. Users may not see updated radiation doses after making changes.

  • Contact RaySearch Laboratories for a software update or patch
  • Verify your RayStation version matches the affected versions (17.0.0, 17.0.1, RayStation v2025, or RayStation v2025 SP1)
  • Review recent treatment plans using the affected software for accuracy
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
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStation v2025, RayStation v2025 SP1 Product Description: Radiation Therapy Treatment Planning System Component: No

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1110-2026

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