RAYSEARCH LABORATORIES AB Recall 94388
Description: RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment Planning System.
RAYSEARCH LABORATORIES AB Recall 94388 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1750-2024 |
| Event ID | 94388 |
| Event Description | RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment Planning System. |
| Product Type | Devices |
| Distribution | 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. |
| Quantity | 128 units |
| Recall Reason | Potential for reported SSD to be too high. |
| Device Classification | 20240508 |
| Device Code Info | 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. |
| Center Classification Date | 20240501 |
| Recall Initiation Date | 20240328 |
| Recalling Firm | RAYSEARCH LABORATORIES AB |
| Similar To |