Recall Z-0115-2016— Viewray Incorporated
Class II · Terminated
Class II FDA medical device recall by Viewray Incorporated, initiated 2015-08-27, terminated 2017-06-09. It names one FDA 510(k) clearance: K111862. Product: 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.. 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..
- Recalling firm
- Viewray Incorporated
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-08-27
- Terminated
- 2017-06-09
- Firm location
- Oakwood Village, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.