FDA-Device2016-10-19Class II
Radiation Therapy Treatment Planning System, Model 5.0
RAYSEARCH LABORATORIES AB
Hazard
For a treatment plan consisting of multiple beam sets, the table for ROI plan dose statistics in the report may show the statistics for a beam set dose. The error can only be triggered when using a report template where statistics for a beam set dose is included as the last dose statistics prior to the plan dose statistics.
Sold states
AZ, CA, FL, MT, NC NY, TX, OH & WA
Affected count
491 units (187 domestically & 304 internationally)
Manufactured in
Sveavaegen 9, N/A, Stockholm, N/A, Sweden
Products
Radiation Therapy Treatment Planning System, Model 5.0
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0079-2017Don't want to check this manually?
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