Device product
RayStation 9.1.0.933 and 9.2.0.483. Radiation Therapy Treatment Planning System.
Z-1745-2024
Product summary
- Event
- Event 94388
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 11 units
- Official record key
device-enforcement:Z-1745-2024
Official wording
Reason: Potential for reported SSD to be too high.
Code information: UDI: 0735000201026620191220 and 0735000201029720200310; GTIN: 07350002010266 and 07350002010297; Serial Numbers: 9.1.0.933 and 9.2.0.483; Expiration Date: 2025-03-31.
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.