Recall Z-0848-2022 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
TomoHelical and TomoDirect plans in RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B and 11A. Build Numbers: 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52, 10.1.0.613, 11.0.0.951 or 11.0.1.29.
| Date | Sep 9, 2021 |
| Status | Terminated |
| Reason | If the dynamic jaw mode is used and an optimization is continued after changing the dose grid or modifying the target ROI, the positions of the jaws may change unexpectedly for some control points. User must be aware to avoid unnecessary jaw openings during treatment planning |
| Root cause | Under Investigation by firm |
| Action | RaySearch issued Field Safety Notice, Medical Device Correction #83773 notice via email on Sept. 9, 2021. Letter states reason for recall, health risk and action to take: ACTIONS TO BE TAKEN BY THE USER " Avoid changing the dose grid after starting an optimization of TomoHelical and TomoDirect plans with dynamic jaw mode. " Always reset the optimization after editing the dose grid for TomoHelical and TomoDirect plans with dynamic jaw mode. " Always reset the optimization after modifying the target ROI. " It is recommended to use the BEV to inspect the jaw positions superior and inferior to th |
| Quantity | 51 (US) Licenses |
| Distribution | US Nationwide distribution in the states of AL, CA, FL, GA, IA, IL, MO, MS, NC, OK, OR, SC, TN, WA, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K210645 | RayStation 10.1 RaySearch Laboratories AB (PUBL), Jun 29, 2021 |