RAYSEARCH LABORATORIES AB: Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1.3 Software Version: RayStation 2023B,

Company / brand

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 / 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.

Classification

Class II

Status

Ongoing

Distribution / sold at

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

Recall initiated

2025-11-28

Code info

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

Product quantity

119

Voluntary mandated

Voluntary: Firm initiated

City

Stockholm

Country

Sweden

Event id

98117

Get the daily digest, and tell us what to watch. Everything is optional except your email.