FDA-Device2026-01-28Class IIPROCESSING DEFECT

RayStation radiation therapy planning software recalled for dose calculation errors

OTHERNationwide distribution

Check RayStation software versions for dose calculation bug

RayStation versions 12A, 12A SP1, and 12A SP2 contain a software bug that prevents dose calculations from updating properly when certain regions are edited. This affects only specific region types (Bolus, Fixation, Support) with no contours that have material overrides. Users may not see updated radiation doses after making changes.

  • Check if your RayStation installation is version 13.0.0.1547, 13.1.0.144, or 13.1.1.89
  • Contact RaySearch Laboratories for a software update or patch
  • Do not rely on dose calculations for affected regions until your system is updated
  • Verify any treatment plans created with these versions 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
8
Manufactured in
Eugeniavagen 18c, Stockholm, Sweden
Products
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Software Version: RayStation 12A, RayStation 12A SP1, RayStation 12A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1105-2026

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief