Recall Z-1954-2015 ยท IYE Accelerator, Linear, Medical
Viewray Incorporated
Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
| Date | Jul 2, 2015 (initiated May 7, 2015) |
| Status | Terminated |
| Reason | The software was failing to determine new patient locations if imaging is not enabled during treatment. |
| Root cause | Software design |
| Action | On May 7, 2015 the firm sent Customer Advisory Notification Letters to their customers. |
| Quantity | 3 |
| Distribution | Distributed in the states of CA, MO & WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111862 | VIEWRAY SYSTEM Viewray, Incorporated, May 22, 2012 |