RAYSEARCH LABORATORIES AB recalls Brand Name: RayStation Product Name: RayStation/RayPlan

Recalling company

RAYSEARCH LABORATORIES AB

Product

Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1.3 Software Version: RayStation 2023B, RayStation 2024A, RayStation 2024A SP3 Product Description: Radiation Therapy Treatment Planning System Component: No

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

119

Lot / codes

Lot Code: UDI: 0735000201055620230630, 0735000201072320231213, 0735000201088420250129 GTIN: 07350002010556, 07350002010723, 07350002010884 Serial Numbers: 14.0.0.3338, 15.0.0.430, 15.1.3.10 Software Revisions: RayStation 2023B, RayStation 2024A, RayStation 2024A SP3 Expiration Date: 2030-02-21

Company location

Stockholm

Recall type

Voluntary: Firm initiated

Recall number

Z-1106-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1106-2026 in the FDA Enforcement Report. Also see FDA recall press releases.