Recall Z-0806-2016 ยท IYE Accelerator, Linear, Medical
Viewray Incorporated
MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.
| Date | Feb 12, 2016 (initiated Dec 24, 2015) |
| Status | Terminated |
| Reason | The system loaded a completion fraction in the incorrect order after a treatment interruption. |
| Root cause | Software design |
| Action | ViewRay sent an Customer Advisory Notice dated December 24, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Workaround: If you want to move a completion plan to a later date in the Delivery Calendar then do not schedule it until right before you are ready to treat that completion plan. While we will address this issue in the next release of software we recommend that in the event of a completion plan you always review the plan name loaded on the TPDS and verify the remaining time and beams are as expected |
| Quantity | 5 units |
| Distribution | US Distribution to the states of : CA, FL, MO & WI., and Internationally to Republic of Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111862 | VIEWRAY SYSTEM Viewray, Incorporated, May 22, 2012 |