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RAYSEARCH LABORATORIES AB recalls RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation
Recalled April 1, 2015 · FDA recall Z-1310-2015 · RAYSEARCH LABORATORIES AB
Hazard
An issue with photon dose calculation for DMLC (Dynamic MLC) plans for machines where the MLC is positioned above the jaws, e.g. some Elekta linacs. The magnitude of the error depends on the beam model output factor corrections and on the individual DMLC plan characteristics. · FDA Class II
Units
Domestic: 245 units
Sold at
Nationwide Distribution.
Description
An issue with photon dose calculation for DMLC (Dynamic MLC) plans for machines where the MLC is positioned above the jaws, e.g. some Elekta linacs. The magnitude of the error depends on the beam model output factor corrections and on the individual DMLC plan characteristics.
Product
RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RayStation 4.7, the issue applies also to machines with fixed jaws, regardless of MLC/jaw position. RayStation is a software system designed for treatment planning and analysis of radiation therapy.
Manufacturer(s)
RAYSEARCH LABORATORIES AB
Made in
Sweden
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →