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RAYSEARCH LABORATORIES AB recalls RayStation 11B
Recalled July 6, 2022 · FDA recall Z-1299-2022 · RAYSEARCH LABORATORIES AB
Hazard
This notice concerns two issues found related to the display of Linear Energy Transfer (LET) in RayStation 11B including some service packs. First, when using a dose threshold for an evaluation dose, LET display might be misleading. Second, a displayed beam-specific LET distribution can sometimes be out of sync with the selected beam. · FDA Class II
Units
26
Sold at
US Nationwide distribution in the states of NJ and TX.
Description
This notice concerns two issues found related to the display of Linear Energy Transfer (LET) in RayStation 11B including some service packs. First, when using a dose threshold for an evaluation dose, LET display might be misleading. Second, a displayed beam-specific LET distribution can sometimes be out of sync with the selected beam.
Product
RayStation 11B
Manufacturer(s)
RAYSEARCH LABORATORIES AB
Made in
Sweden
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →