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RAYSEARCH LABORATORIES AB recalls RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system designed for tre
Recalled April 9, 2014 · FDA recall Z-1307-2014 · RAYSEARCH LABORATORIES AB
Hazard
Potential for dose errors due to software program errors. · FDA Class II
Units
151 units Total (88 units domestically & 63 units internationally)
Sold at
Worldwide Distribution - US including the states of NY, OH, MD, CT, CO, TN, IL, AZ, MS, NJ, PA, DE, FL, CA and WA., and the countries of New Zealand, Australia, Republic of Korea, China, Italy, Germany, Norway, Belgium, Switzerland, United Kingdom and Spain.
Description
Potential for dose errors due to software program errors.
Product
RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system designed for treatment planning and analysis of radiation therapy.
Manufacturer(s)
RAYSEARCH LABORATORIES AB
Made in
Sweden
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →