Recall Z-1189-2025 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
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
| Date | Feb 19, 2025 (initiated Jan 16, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | Raysearch issued Field Safety Notice, Medical Device Correction #148655 RayStation version 4.5 to 2024B including some service packs via email on 1/17/25. Letter states reason for recall, health risk and action to take: For users of HU-to-mass density CT calibration curves If a user wants to evaluate a plan with respect to relative stopping power/WE range error rather than mass density errors, there are two options: Option 1. Use a HU-to-SPR CT calibration curve instead of a HU-to-mass density curve. " For evaluation of an existing case, the evaluation can be done on an anonymized and export |
| Quantity | 6 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211867 | RayStation 11.0 RaySearch Laboratories AB (PUBL), Sep 8, 2021 |