FDA-Device2026-01-28Class IIPROCESSING DEFECT

RayStation 2024B radiation therapy software recalled for dose calculation error

OTHERNationwide distribution

Update RayStation 2024B software immediately

RayStation version 2024B has a software issue where calculated radiation doses may not update 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. Clinics using this version should verify their dose calculations are accurate.

Contact RaySearch Laboratories for a software update or patch
Review recent treatment plans using version 2024B to ensure dose calculations are correct
Do not proceed with treatment if dose recalculation appears incorrect
Check your facility's distribution list to confirm if your system 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

Manufactured in

Eugeniavagen 18c, Stockholm, Sweden

Products

Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 2024B Product Description: Radiation Therapy Treatment Planning System Component: No

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1109-2026

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