Recall Z-2492-2025 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStation 11B Service Pack 1, Software Version: 12.1.0.1221. 3. RayStation 11B Service Pack 2, Software Version: 12.0.3.68. 4. RayStation 11B Service Pack 3, Software Version: 12.0.4.12. 5. RayStation 11B Service Pack Toshiba 1, Software Version: 12.3.0.119. Product Description: Radiati
| Date | Sep 2, 2025 (initiated Aug 8, 2025) |
| Status | Open, Classified |
| Reason | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique. |
| Root cause | Under Investigation by firm |
| Action | RaySearch notified consignees on about 08/08/2025 via email. Consignees were informed that as temporary solution, affected objects can be re-exported via RayGateway to generate new UIDs. They were instructed to inform planning staff and all users about this workaround, inspect your product and identify all installed units with the above software version number(s), and complete and return the response form. The issue will be resolved in the next version of RayStation, scheduled for market release in December 2025 (subject to market clearance in some markets). If customers wish to continue usin |
| Quantity | 6 |
| Distribution | Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, IL, IA, KY, LA, MD, MN, MS, NY, NC, OH, OK, SC, WA, WI and the countries of Canada, China, Colombia, France, Germany, Hong Kong S.A.R., China, Italy, Japan, Netherlands, Poland, Spain, Sweden, Switzerland, ENG, Thailand, Turkey, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K220141 | RayStation 11B RaySearch Laboratories AB (PUBL), Apr 15, 2022 |