RecalledThisWeek Search
Medium risk Drugs & MedicationsClass II

RAYSEARCH LABORATORIES AB Recall

Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 2024B Product Description:

Updated November 28, 2025

RAYSEARCH LABORATORIES AB is recalling Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 2024B Product Description:. 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.

Is the RAYSEARCH LABORATORIES AB recalled? Yes. This product was recalled by FDA on November 28, 2025. Details below.

What is recalled

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

Am I affected

You may be affected if you own this product. Check the brand, model, and lot/date codes listed in the recall against your item.

What to do right now

Voluntary: Firm initiated

The 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.

Brands affected

RAYSEARCH LABORATORIES AB
Source
FDA
Category
Drugs & Medications
Recall ID
fda-Z-1109-2026
Classification
Class II
Recalled
November 28, 2025
Read the official notice

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