Device product
RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy Treatment Planning System.
Z-1746-2024
Product summary
- Event
- Event 94388
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 213 units
- Official record key
device-enforcement:Z-1746-2024
Official wording
Reason: Potential for reported SSD to be too high.
Code information: UDI: 0735000201030320200526, 0735000201036520200526 and 0735000201065520220608; GTIN: 07350002010303, 07350002010365 and 07350002010655; Serial Numbers: 10.0.0.1154, 10.0.1.52 and 10.0.2.10; Expiration Date: 2025-06-16.
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.