FDA-Device2014-04-30Class II
RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0.
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.
Sold states
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.
Affected count
251 units (148 units domestically & 103 units internationally)
Manufactured in
Sveavaegen 9, N/A, Stockholm, N/A, Sweden
Products
RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1481-2014Don't want to check this manually?
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