Recall Z-0849-2022 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
RayStation/RayPlan versions 4 - 11A, including service packs. Build Stations: 4.0.0.14, 4.0.3.4, 4.3.0.14, 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 4.7.6.7, 4.9.0.42, 5.0.1.11, 5.0.2.35, 5.0.3.17, 6.0.0.24, 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 22, 2021 |
| Status | Open, Classified |
| Reason | An issue where the combined density in a dose grid voxel partially covered by the External ROI and also partially covered by an ROI of type Bolus, Support or Fixation may be unexpected.The density in the voxel can be both under- and overestimated |
| Root cause | Device Design |
| Action | RaySearch issued Field Safety Notice, Medical Device Correction #84236 via E-mail on 22 September 2021. Letter states reason for recall, health risk and action to take: " Use the automatic tool in RayStation/RayPlan to create the External ROI. " When using a Support or Fixation ROI of tissue-like material (density around 1), extend this ROI a few millimeters inside the External ROI to cover the surface voxels of the patient. " If the Support or Fixation ROI differs significantly from the adjacent body tissue, an extra help ROI with material override set to a suitable material, for example, Ski |
| Quantity | 478 licenses US |
| Distribution | US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211867 | RayStation 11.0 RaySearch Laboratories AB (PUBL), Sep 8, 2021 |