Recall Z-1309-2016 ยท IYE Accelerator, Linear, Medical
Viewray Incorporated
MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the MRIdian System) is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated
| Date | Mar 31, 2016 (initiated Mar 7, 2016) |
| Status | Terminated |
| Reason | When editing the isocenter or the couch position of the plan while in the treatment workflow (in the Points screen) and re-optimizing, the software will not prompt the user to shift the couch to the new isocenter. As a result there is the potential to deliver dose to the initial isocenter rather than the new location. |
| Root cause | Software design |
| Action | ViewRay sent an Urgent Device Correction letter dated March 7, 2016. The letter identified the product, the problem, and the action to be taken by the customer. Customers with questions were instructed to contact ViewRay Customer Support at support@viewray.com or call the ViewRay Customer Support center at 855-286-8875. |
| Quantity | 5 units |
| Distribution | Worldwide Distribution - US including CA, FL, MO & WI., and International distribution to the Republic of Korea and The Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111862 | VIEWRAY SYSTEM Viewray, Incorporated, May 22, 2012 |