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RAYSEARCH LABORATORIES AB recalls RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) a
Recalled July 10, 2019 · FDA recall Z-1930-2019 · RAYSEARCH LABORATORIES AB
Hazard
When calculating electron Monte Carlo dose with a very large number of histories, the dose calculation may be wrong · FDA Class II
Units
744
Sold at
US Nationwide Distribution
Description
When calculating electron Monte Carlo dose with a very large number of histories, the dose calculation may be wrong
Product
RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RayStation 6) . Intended Use: 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 →