FDA Device recall Z-0115-2016
MRIdian¿ ViewRay¿ Radiation Therapy System, ViewRay¿ Is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tum…
- FDA Device
- Class II
- terminated
- Published 2015-10-21
On 2015-10-21 the FDA classified a Class II recall of MRIdian¿ ViewRay¿ Radiation Therapy System, ViewRay¿ Is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tum… by Viewray, citing 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 un….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0115-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-27 |
| Published | 2015-10-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Viewray |
| Distribution | CA, MO, WI |
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.
Identifiers
| code_info | Catalog/Part Number: 10000; Serial Numbers: 100, 101, 102, & 105 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0115-2016%22
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