Device product
RayStation 14.0.0.3338. Radiation Therapy Treatment Planning System.
Z-1751-2024
Product summary
- Event
- Event 94388
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 49 units
- Official record key
device-enforcement:Z-1751-2024
Official wording
Reason: Potential for reported SSD to be too high.
Code information: UDI: 0735000201055620230630; GTIN: 07350002010556; Serial Numbers: 14.0.0.3338; Expiration Date: 2028-07-07.
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.