Recall Z-2457-2015 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment Planning System, for treatment planning and analysis of radiation therapy.
| Date | Aug 25, 2015 (initiated May 27, 2015) |
| Status | Terminated |
| Reason | Issue with the algorithm for ROI contraction in RayStation 4.7 when non-uniform contraction distances are used. The ROI contraction tool uses six distances as input: right/left, inferior/superior and posterior/anterior. These contraction distances are, in error, pairwise reversed, i.e. right is interpreted as left, inferior is interpreted as superior, and posterior is interpreted as anterior. |
| Root cause | Software design |
| Action | On May 27, 2015 RaySearch Laboratories distributed Medical Device Correction notices to their customers via courier service. Within the Medical Device Correction notice, RaySearch Laboratories included a workaround to the problem for their customers. Customers should not use structure templates containing derived ROI definitions with non-uniform contractions. They should avoid using non-uniform contractions. In the case non-uniform contractions must be used, enter switched distances manually and review the result carefully before using it for treatment planning. Lastly, do not use humerus |
| Quantity | 126 programs |
| Distribution | Distributed in CO, IL, MI, NC, OH,TN, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141860 | RAYSTATION Raysearch Laboratories AB, Oct 23, 2014 |