RAYSEARCH LABORATORIES AB — Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B SP1 Product Description: Radiation Therapy Treatme
⚠️ 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 this relevant to me?
- Geography
- US
- Source agency
- FDA
- Category
- Health
- Published
- November 28, 2025
Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS
What's affected?
- Product
- Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B SP1 Product Description: Radiation Therapy Treatment Planning System Component: No
- Lot code
- UDI:
Additional details
Lot Code: UDI: 0735000201047120220131 GTIN: 07350002010471 Serial Numbers: 10.1.1.54 Software Revision: RayStation 10B SP1 Expiration Date: 2027-02-01
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 0.
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