Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
RayStation Therapy Treatment Planning System Recalled by RAYSEARCH LABORATORIES AB Due to Under some circumstances, imported CT, MR and PET...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact RAYSEARCH LABORATORIES AB directly.
Affected Products
RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment. RayStation is a software system designed for treatment planning and analysis of radiation therapy.
Quantity: Domestic: 70 units; Foreign: 27 units
Why Was This Recalled?
Under some circumstances, imported CT, MR and PET images are offset from their true positions by one pixel in one or two directions. Users must be aware of this information to avoid incorrect dose calculations during treatment planning.
Where Was This Sold?
Worldwide Distribution - USA including Connecticut, Florida, Massachusetts, Missouri, New York, Ohio, and foreign distribution to(Canada, Italy, Australia, Germany, Netherlands, and Switzerland.
About RAYSEARCH LABORATORIES AB
RAYSEARCH LABORATORIES AB has 113 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report