Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
RayStation 8B Service Pack 1 Recalled by RAYSEARCH LABORATORIES AB Due to Software error was identified in the Pencil Beam...
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 8B Service Pack 1, UDI # 07350002010204 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Quantity: N/A
Why Was This Recalled?
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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