Company: RAYSEARCH LABORATORIES AB
Date of Enforcement Report: 5/1/2-24
Class II
PRODUCT
RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System
Recall Number:
Z-1742-2024
REASON:
Potential for reported SSD to be too high.
RECALLING FIRM/MANUFACTURER:
RAYSEARCH LABORATORIES AB
VOLUME OF PRODUCT IN COMMERCE:
9 units
DISTRIBUTION:
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.
