RAYSEARCH LABORATORIES AB — RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatment Planning System
⚠️ 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
- RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatment Planning System
- Lot code
- UDI: 0735000201031020201216. GTIN: 07350002010310. Serial Numbers: 10.1.0.613. Software Revision: RayStation 10B. Expiration Date: 2027-02-01.
Additional details
UDI: 0735000201031020201216. GTIN: 07350002010310. Serial Numbers: 10.1.0.613. Software Revision: RayStation 10B. Expiration Date: 2027-02-01.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 0.
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