International safety notice

As a result of an investigation by the overseas manufacturer, the following malfunction events (1) to (6) (below) have occurred due to bugs in this item (software). It has been confirmed that the following problem (hereinafter referred to as the problem) may occur. We have decided to implement a voluntary recall of the upgrade to the next version. (1) Our management number: FSN 74977 Versions affected by the bug: "4.7.4.4", "6.2.0.7", "6.3.0.6", "9.0.0.113", "10.0.1.52" Target facilities: 179 Number of target licenses: 389 Summary of malfunction event: In some LINACs, when the clinical dose beam is summed with the approximate dose beam, the approximate dose is incorrect. may be labeled as a clinical dose. (2) Our management number: FSN 78320 / FSN 29294 Versions affected by the bug: "6.2.0.7", "6.3.0.6", "9.0.0.113", "10.0.1.52" Target facilities: 206 Number of target licenses: 504 Summary of malfunction event: [FSN 78320] Voxelwise worst dose distribution (voxelwise min depending on the type of clinical goal) voxelwise max), the clinical goal result is updated from the previous value when evaluating the clinical goal. There is a possibility that the [FSN 29294] Due to the effect of 3D reconstruction on RayStation, issues related to contour drawing when the CT slice interval is 1 mm or less. Elephants may occur. may appear on the bottom slice. (3) Our management number: FSN 83773 Versions affected by the bug: "6.2.0.7", "6.3.0.6", "9.0.0.113", "10.0.1.52" Target facilities: 34 Number of target licenses: 51 Summary of malfunction: In TomoHelical and TomoDirect plans, when using dynamic jaw mode, If you continue optimization after changing the lid or changing the target ROI, some control points The position of the jaws may change unexpectedly. (4) Our management number: FSN 84236 Versions affected by the bug: "4.7.4.4", "6.2.0.7", "6.3.0.6", "9.0.0.113", "10.0.1.52" Target facilities: 151 Number of target licenses: 348 Summary of malfunction: This item is used in plans for electron beams, proton beams, helium beams (no applicable facilities in Japan), and carbon beams., dose grid partially covered by body contour ROI and bolus, support, or fixture type ROI If there is a voxel, the density within that voxel may not be the expected value, and the voxel's density may be undervalued. Both valuation and overestimation can occur. (5) Our management number: FSN 93572 Versions affected by the bug: "4.7.4.4", "6.2.0.7", "6.3.0.6", "9.0.0.113", "10.0.1.52" Target facilities: 185 Number of target licenses: 405 Summary of the malfunction: The SSD calculation algorithm missed the ROI entrance point, calculated the distance to the exit point, SSD calculation result values ​​are inaccurate in GUI, planning report, DICOM export, or scripting When accessing the SSD, the value of the SSD may not be displayed accurately. (6) Our management number: FSN 109886 Versions affected by the bug: "9.0.0.113", "10.0.1.52" Target facilities: 4 Number of target licenses: 7 Problem summary: The Virtual Simulation module allows setting a non-zero collimator angle; When a plan is exported in DICOM using the button labeled “VISIM Export”, the user interface Although the angles on the base are accurate, the angles may no longer be accurate in the exported radiation treatment plan. be. When the image is imported into this item, it is imported as a Virtual Simulation plan, so doses can be calculated based on it. Once calculated, it will match the plan for this item, but may not match the original plan.

Japan / PMDA Recalls · JPN · Mar 15, 2024