PlainRecalls
FDA Devices Moderate Class II Ongoing

Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RayStation 2024A SP1, RayStation 2024A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No

Reported: January 28, 2026 Initiated: November 28, 2025 #Z-1108-2026

Product Description

Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RayStation 2024A SP1, RayStation 2024A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No

Reason for Recall

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.

Details

Recalling Firm
RAYSEARCH LABORATORIES AB
Units Affected
0
Distribution
Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS
Location
Stockholm

Frequently Asked Questions

What product was recalled? ▼
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RayStation 2024A SP1, RayStation 2024A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No. Recalled by RAYSEARCH LABORATORIES AB. Units affected: 0.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 28, 2026. Severity: Moderate. Recall number: Z-1108-2026.

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