RAYSEARCH LABORATORIES AB Recall 96156
Description: Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 1.0.0.951, 11.0.1.29, 11.0.3.116 and 11.0.4.15 Software Revisions: RayStation 11A and 11A Service Pack 1, 2 and 3
RAYSEARCH LABORATORIES AB Recall 96156 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1189-2025 |
| Event ID | 96156 |
| Event Description | Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 1.0.0.951, 11.0.1.29, 11.0.3.116 and 11.0.4.15 Software Revisions: RayStation 11A and 11A Service Pack 1, 2 and 3 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Belgium ENG, Canada, China, China APactron, Denmark, France, Germany, Hong Kong S.A.R. China, India, Italy, Japan, Korea, Netherlands, Norway, Poland, Singapore, Spain, SwitzerlandENG, Taiwan, Thailand, UK. |
| Quantity | 6 |
| Recall Reason | Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs. |
| Device Classification | 20250226 |
| Device Code Info | Lot Code: UDI: 0735000201038920210518, 0735000201043320210610, 0735000201044020210916 and 0735000201063120220616 GTIN: 07350002010389, 07350002010433, 07350002010440 and 07350002010631 Serial Numbers: 11.0.0.951, 11.0.1.29, 11.0.3.116 and 11.0.4.15 Software Revisions: RayStation 11A and 11A Service Pack 1, 2 and 3 Expiration Date: 2027-06-22 |
| Center Classification Date | 20250219 |
| Recall Initiation Date | 20250116 |
| Recalling Firm | RAYSEARCH LABORATORIES AB |
| Initial Notification | |
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