Device product
RayStation 9.0.0.113 and 9.0.1.142. Radiation Therapy Treatment Planning System.
Z-1744-2024
Product summary
- Event
- Event 94388
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 63 units
- Official record key
device-enforcement:Z-1744-2024
Official wording
Reason: Potential for reported SSD to be too high.
Code information: UDI: 0735000201017420190612 and 0735000201048820220420; GTIN: 07350002010174 and 07350002010488; Serial Numbers: 9.0.0.113 and 9.0.1.142; Expiration Date: 2027-12-15.
Distribution pattern: 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.
Derived failure modes
-
Unknown
Potential for reported SSD to be too high.