Recall Weekly← all recalls
FDA-Device2026-01-28Class IIPROCESSING DEFECT

RayStation radiation therapy software recalled for dose calculation error

Raysearch Laboratories
OTHERNationwide distribution

Check RayStation software versions 2024A SP1 and SP2

RayStation radiation therapy planning software versions 2024A SP1 and 2024A SP2 have a bug that prevents dose calculations from updating correctly when certain regions of interest (ROIs) are modified. This affects ROIs without contours that have material overrides or are classified as Bolus, Fixation, or Support types. If changes are made to these ROIs, the system may not recalculate doses as intended.

  • Verify your RayStation software version (15.1.3 or 15.2.0)
  • Contact RaySearch Laboratories for patched software or workaround instructions
  • Review any treatment plans created or modified with affected ROI types for accuracy
  • Do not proceed with treatments until dose calculations are verified correct
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: 15.2.0, 15.1.3 Software Version: RayStation 2024A SP1, RayStation 2024A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1108-2026

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