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RAYSEARCH LABORATORIES AB recalls RayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4.0, 4.5 and 4.7., designed for treatment pl
Recalled June 1, 2016 · FDA recall Z-1712-2016 · RAYSEARCH LABORATORIES AB
Hazard
A software issue with editing tools that use the left mouse button held down, for drawing in and interacting with the patient views and beams eye views. The views can become unsynchronized with the stored data if simultaneously right clicking, pressing Ctrl-S or Ctrl-Z while the left mouse button is held down. This bug does not affect dose computations, which are based on the stored system state. · FDA Class II
Units
1,264 Total units (552 units domestically & 711 units internationally)
Sold at
**Domestic** AR, AZ, CA, CT, CO, DE, FL, GA, IL, LA, MI, MD, MS, MA, NY, NV, NJ, OH, OR, PA, NC, RI, TN, WA & Washington D.C; **Internationally** Algeria, Australia, Austria, Belgium, Canada, China, France, French Polynesia, Germany, Iran, Italy, Japan, Netherlands, New Zealand, Norway, Republic of Korea, Spain, Sweden, Switzerland, Thailand & United Kingdom
Description
A software issue with editing tools that use the left mouse button held down, for drawing in and interacting with the patient views and beams eye views. The views can become unsynchronized with the stored data if simultaneously right clicking, pressing Ctrl-S or Ctrl-Z while the left mouse button is held down. This bug does not affect dose computations, which are based on the stored system state.
Product
RayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4.0, 4.5 and 4.7., 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 →