Z-1746-2024 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
- 213 units
Product Description
RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. 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: 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.