FDA-Device2020-03-18Class II
RayStation/RayPlan 8A Service Pack 1, Build Number 8.0.1.10, stand-alone software treatment planning system
RAYSEARCH LABORATORIES AB
Hazard
There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect.
Sold states
The products were distributed to the following US states: TN
Affected count
1 system in the U.S.
Manufactured in
Sveavagen 9, Stockholm, Sweden
Products
RayStation/RayPlan 8A Service Pack 1, Build Number 8.0.1.10, stand-alone software treatment planning system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1463-2020Don't want to check this manually?
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