RAYSEARCH LABORATORIES AB Recall 94388
Description: RayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5. Radiation Therapy Treatment Planning System.
RAYSEARCH LABORATORIES AB Recall 94388 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1743-2024 |
| Event ID | 94388 |
| Event Description | RayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5. 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 | 5 units |
| Recall Reason | Potential for reported SSD to be too high. |
| Device Classification | 20240508 |
| Device Code Info | UDI: 0735000201011220180608 and 0735000201013620180928; GTIN: 07350002010112 and 07350002010136; Serial Numbers: 8.0.0.61 and 8.0.1.10; Expiration Date: 2024-06-05. |
| Center Classification Date | 20240501 |
| Recall Initiation Date | 20240328 |
| Recalling Firm | RAYSEARCH LABORATORIES AB |
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