Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
RayStation 4.7 Recalled by RAYSEARCH LABORATORIES AB Due to Issue with the algorithm for ROI contraction in...
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 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment Planning System, for treatment planning and analysis of radiation therapy.
Quantity: 126 programs
Why Was This Recalled?
Issue with the algorithm for ROI contraction in RayStation 4.7 when non-uniform contraction distances are used. The ROI contraction tool uses six distances as input: right/left, inferior/superior and posterior/anterior. These contraction distances are, in error, pairwise reversed, i.e. right is interpreted as left, inferior is interpreted as superior, and posterior is interpreted as anterior.
Where Was This Sold?
This product was distributed to 7 states: CO, IL, MI, NC, OH, TN, WA
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