Reported Jan 28, 2026 · Ongoing
RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStation…
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?
- RayStation/RayPlan
- Model/Catalog Numbers
11.0.011.0.111.0.311.0.4
- Software VersionRayStation 11A, RayStation 11A SP1, RayStation 11A SP2, RayStation 11A SP3. Radiation Therapy Treatment Planning System
- Lot codes and dates
- Lot Code
UDI: 07350002010389202105180735000201043320210610073500020104402021091635000201063120220616
- GTIN
07350002010389073500020104330735000201044007350002010631
- Serial Numbers
11.0.0.95111.0.1.2911.0.3.11611.0.4.15
- Software Revision
RayStation 11A11A SP111A SP211A SP3
- Expiration Date2027-06-22
- Lot Code
- Amount recalled
- 10 units
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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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