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RAYSEARCH LABORATORIES AB recalls RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
Recalled April 9, 2014 · FDA recall Z-1308-2014 · RAYSEARCH LABORATORIES AB
Hazard
RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy. · FDA Class II
Units
19 units (16 units domestically & 3 units internationally)
Sold at
OH, MD, NJ, WA, IL, MA, FL, Spain, United Kingdom, Italy,
Description
RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy.
Product
RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
Manufacturer(s)
RAYSEARCH LABORATORIES AB
Made in
Sweden
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →