RAYSEARCH LABORATORIES AB 2026-01-28 Health serious FDA
Health · FDA · Recall #FDA-Z-1109-2026
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 … Recall
Issued January 28, 2026 · RAYSEARCH LABORATORIES AB
In January 2026, RAYSEARCH LABORATORIES AB recalled the Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 …, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 … right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact RAYSEARCH LABORATORIES AB to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- RAYSEARCH LABORATORIES AB
- Category
- Health
- Recall date
- January 28, 2026
- Units affected
- Not reported
- Sold at
- Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS
- Recall number
- FDA-Z-1109-2026
- Made in
- Sweden
- Issuing agency
- FDA
In context
- RAYSEARCH LABORATORIES AB has 9 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 356th Health recall we've logged in 2026.