Recall Z-1712-2016 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
RayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4.0, 4.5 and 4.7., designed for treatment planning and analysis of radiation therapy.
| Date | May 25, 2016 (initiated Feb 10, 2016) |
| Status | Terminated |
| Reason | A software issue with editing tools that use the left mouse button held down, for drawing in and interacting with the patient views and beams eye views. The views can become unsynchronized with the stored data if simultaneously right clicking, pressing Ctrl-S or Ctrl-Z while the left mouse button is held down. This bug does not affect dose computations, which are based on the stored system state. |
| Root cause | Other |
| Action | On February 10, 2016, RaySearch Laboratories distributed Field Safety, Medical Device Correction notices and Reply Forms to their customers via email. To determine if the software version you are using is affected, open the About RayStation dialog in the RayStation application and check if the build number reported. This bug does not affect dose computations. Dose is always computed based on the stored system state. Actions to be taken by the user include the following: Always release the left mouse button before using other keys or mouse buttons, If the warning message "Temporary items sho |
| Quantity | 1,264 Total units (552 units domestically & 711 units internationally) |
| Distribution | **Domestic** AR, AZ, CA, CT, CO, DE, FL, GA, IL, LA, MI, MD, MS, MA, NY, NV, NJ, OH, OR, PA, NC, RI, TN, WA & Washington D.C; **Internationally** Algeria, Australia, Austria, Belgium, Canada, China, France, French Polynesia, Germany, Iran, Italy, Japan, Netherlands, New Zealand, Norway, Republic of |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141860 | RAYSTATION Raysearch Laboratories AB, Oct 23, 2014 |