FDA-Device2022-07-06Class II
RayStation 11B
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.
Sold states
US Nationwide distribution in the states of NJ and TX.
Affected count
26
Manufactured in
Sveavagen 9, Stockholm, Sweden
Products
RayStation 11B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1299-2022Don't want to check this manually?
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