Reported Jan 28, 2026 · Ongoing
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B…
Raysearch Laboratories Ab
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: RAYSEARCH LABORATORIES AB · Eugeniavagen 18c · Stockholm · N/A
Is this the product you have?
- Brand NameRayStation
- Product NameRayStation/RayPlan
- Model/Catalog Number10.1.1
- Software VersionRayStation 10B
- SP1 Product DescriptionRadiation Therapy
- Treatment Planning System ComponentNo
- Lot codes and dates
- Lot CodeUDI: 0735000201047120220131
- GTIN07350002010471
- Serial Numbers10.1.1.54
- Software RevisionRayStation 10B
- SP1 Expiration Date2027-02-01
- Amount recalled
- 0
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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