Recall Z-2085-2015 ยท IYE Accelerator, Linear, Medical
Viewray Incorporated
Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
| Date | Jul 16, 2015 (initiated Apr 1, 2015) |
| Status | Terminated |
| Reason | ViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot. |
| Root cause | Software Design Change |
| Action | ViewRay sent a Customer Advisory Notification Letters dated April 1, 2015 to thier customers. The letter identified the affected product, problem and actions to be taken. For questions or concerns regarding this issue, contact ViewRaylM Customer Support at support@viewray.com or call the ViewRaylM Customer Support center at 855-286-8875. |
| Quantity | 3 |
| Distribution | US Nationwide Distribution 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 |