Device product
RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment Planning System.
Z-1750-2024
Product summary
- Event
- Event 94388
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 128 units
- Official record key
device-enforcement:Z-1750-2024
Official wording
Reason: Potential for reported SSD to be too high.
Code information: UDI: 0735000201054920220616, 0735000201067920221007 and 0735000201073020230913; GTIN: 07350002010549, 07350002010679 and 07350002010730; Serial Numbers: 13.0.0.1547, 13.1.0.144 and 13.1.1.89; Expiration Date: 2028-10-05.
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.