Z-1744-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 8, 2024
- Initiation Date
- March 28, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 63 units
Product Description
RayStation 9.0.0.113 and 9.0.1.142. Radiation Therapy Treatment Planning System.
Reason for Recall
Potential for reported SSD to be too high.
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.
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.