Recall Z-1482-2024 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs.
| Date | Apr 5, 2024 (initiated Feb 23, 2024) |
| Status | Open, Classified |
| Reason | A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant. |
| Root cause | Under Investigation by firm |
| Action | On February 26, 2024, the firm notified customers of the issue via Urgent Field Safety Notice: Medical Device Correction letters via email. Actions to be taken by the user: 1. Educate planning staff and all users about the possibility of the described use error. 2. If the use error is deemed likely to occur at your clinic, take actions to ensure that proper review of assigned materials is performed before a patient model is used for treatment planning. 3. If you wish to have the Silicon chemical element removed from the material list, contact RaySearch support for assistance. This is especiall |
| Quantity | 154 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Canada, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Hong Kong S.A.R., Hungary, India, Indonesia, Israel, Italy, Japan, Korea, Malaysia, Morocco, Netherlands, New Zealand, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190387 | RayStation RaySearch Laboratories AB (PUBL), Jun 19, 2019 |
| K200569 | RayStation RaySearch Laboratories AB (PUBL), Sep 24, 2020 |
| K210645 | RayStation 10.1 RaySearch Laboratories AB (PUBL), Jun 29, 2021 |
| K211867 | RayStation 11.0 RaySearch Laboratories AB (PUBL), Sep 8, 2021 |
| K220141 | RayStation 11B RaySearch Laboratories AB (PUBL), Apr 15, 2022 |
| K222312 | RayStation 12A RaySearch Laboratories AB (PUBL), Mar 29, 2023 |