Recall Z-0115-2016 ยท IYE Accelerator, Linear, Medical
Viewray Incorporated
MRIdian ViewRay Radiation Therapy System, ViewRay Is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
| Date | Oct 9, 2015 (initiated Aug 27, 2015) |
| Status | Terminated |
| Reason | ViewRay discovered that in the event that an encoder breaks or fails on the Patient Handling System (PHS, or couch), when attempting to restart the system, the couch could move unexpectedly. |
| Root cause | Device Design |
| Action | ViewRay sent an Customer Advisory Notice dated August 27, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. It is recommended that if you have a patient on the couch and you receive the fault ''The patient table has experienced an unintended movement. This may be due to the patient or operator leaning on the table. Clear the fault and retry. If the problem persists call Service" on the TPDS,first attempt to clear the fault. If it does not clear and requires you to restart the couch software (same switch as restar |
| Quantity | 4 units |
| Distribution | US Distribution to the states of : CA, MO and WI., and Internationally to Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111862 | VIEWRAY SYSTEM Viewray, Incorporated, May 22, 2012 |