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RAYSEARCH LABORATORIES AB recalls RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 an
Recalled April 30, 2014 · FDA recall Z-1481-2014 · RAYSEARCH LABORATORIES AB
Hazard
RaySearch Laboratories has recalled "RaySearch Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0" software due to dose miscalculations for bolus/external/fixation support structures on CT-image. · FDA Class II
Units
251 units (148 units domestically & 103 units internationally)
Sold at
Worldwide Distribution - USA Nationwide in the states of: AZ, CA, CT, CO, DE, FL, IL, NJ, NY, MA, MD, MS, OH, PA, TN, VA and WA. and the countries of Australia, New Zealand, Belgium, New South Wales, Republic of Korea, Italy, Germany, China, France, Switzerland, Netherlands, Spain, Austria, United Kingdom and Norway.
Description
RaySearch Laboratories has recalled "RaySearch Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0" software due to dose miscalculations for bolus/external/fixation support structures on CT-image.
Product
RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0.
Manufacturer(s)
RAYSEARCH LABORATORIES AB
Made in
Sweden
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →