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RAYSEARCH LABORATORIES AB recalls Radiation Therapy Treatment Planning System, Model 5.0
Recalled October 19, 2016 · FDA recall Z-0079-2017 · 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. · FDA Class II
Units
491 units (187 domestically & 304 internationally)
Sold at
AZ, CA, FL, MT, NC NY, TX, OH & WA
Description
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.
Product
Radiation Therapy Treatment Planning System, Model 5.0
Manufacturer(s)
RAYSEARCH LABORATORIES AB
Made in
Sweden
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →