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RAYSEARCH LABORATORIES AB recalls RayStation 14.0.0.3338. Radiation Therapy Treatment Planning System.
Recalled May 8, 2024 · FDA recall Z-1751-2024 · RAYSEARCH LABORATORIES AB
Hazard
Potential for reported SSD to be too high. · FDA Class II
Units
49 units
Sold at
Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK.
Description
Potential for reported SSD to be too high.
Product
RayStation 14.0.0.3338. Radiation Therapy Treatment Planning System.
Manufacturer(s)
RAYSEARCH LABORATORIES AB
Made in
Sweden
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →