FDA-Device2013-11-20Class II
Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0
RAYSEARCH LABORATORIES AB
Hazard
Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees.
Sold states
US Distribution in the states of: California, Colorado, Delaware, Florida, Maryland, Missouri, New Jersey, New York, Ohio, Pennsylvania, Tennessee, and Virginia.
Affected count
195 units domestically
Manufactured in
Sveavaegen 9, Stockholm, Sweden
Products
Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0281-2014Don't want to check this manually?
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