RAYSEARCH LABORATORIES AB 2025-02-26 Health serious FDA
Health · FDA · Recall #FDA-Z-1189-2025
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System … Recall
Issued February 26, 2025 · RAYSEARCH LABORATORIES AB
In February 2025, RAYSEARCH LABORATORIES AB recalled the Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System …, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
What you should do
- 1 Stop using Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System … 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
- February 26, 2025
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Belgium ENG, Canada, China, China APactron, Denmar
- Recall number
- FDA-Z-1189-2025
- 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 691st Health recall we've logged in 2025.