FDA-Device2014-04-09Class II
RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
RAYSEARCH LABORATORIES AB
Hazard
RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy.
Sold states
OH, MD, NJ, WA, IL, MA, FL, Spain, United Kingdom, Italy,
Affected count
19 units (16 units domestically & 3 units internationally)
Manufactured in
Sveavaegen 9, N/A, Stockholm, N/A, Sweden
Products
RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1308-2014Don't want to check this manually?
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