Recall Z-1806-2014 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy.
| Date | Jun 17, 2014 (initiated Apr 25, 2014) |
| Status | Terminated |
| Reason | This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT has variable slice spacing. The dose grid volumetric representation of an ROI can be wrong. This affects all dose-volume properties for such ROIs, including DVH, dose statistics, clinical goals and constraints or objective functions. Furthermore, if material override ROIs are used, or if the external is not represented by contours, the bug can trigger an error in the 3D dose distribution. |
| Root cause | Software design |
| Action | On April 25, 2014, RaySearch emailed all consignees of the affected product a copy of the recall notice as well as the response forms. Back up notification methods include phone calls and site visits. |
| Quantity | 25 sites/245 units (US), 25 sites/124 units (foreign) |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of AZ, CA, FL, IL, MA, MD, MO, MS, NJ, NV, NY, OH, PA, TN, VA, and WA, and the countries of Australia, Belgium, Germany, France, Italy, New Zealand, Republic of Korea, Switzerland, Spain, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130617 | RAYSTATION Raysearch Laboratories AB, May 10, 2013 |