RAYSEARCH LABORATORIES AB recalls Brand Name: RayStation- Intended as a Radiation Therapy Trea
Recalled Product
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 and 12.3.0.119 Software Version: RayStation 11B and 11B Service Pack 1, 2, 3 and Service Pack Toshiba 1
Hazard / Issue
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.
Issued by
FDA
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