RAYSEARCH LABORATORIES AB recalls RayStation/RayPlan.

Recalling company

RAYSEARCH LABORATORIES AB

Product

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

Reason

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Nov 28, 2025

Reported

Jan 28, 2026

Distribution

Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS

Status

Ongoing

Quantity

22 units

Lot / codes

UDI: 0735000201042620211208, 0735000201049520220312, 0735000201050120220422, 0735000201060020220620 and 0735000201057020221222. GTIN: 07350002010426, 07350002010495, 07350002010501, 07350002010600 and 07350002010570. Serial Numbers: 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12, 12.3.0.119. Software Revisions: RayStation 11B, 11B SP1, 11B SP2, 11B SP3, 11B SPT1. Expiration Date: 2028-03-20.

Company location

Stockholm

Recall type

Voluntary: Firm initiated

Recall number

Z-1104-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1104-2026 in the FDA Enforcement Report. Also see FDA recall press releases.