FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0115-2016
- Recalling firm
- Viewray Incorporated
- 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.
- Status
- Terminated
- Initiated
- 2015-08-27
- Posted
- 2015-10-09
- Terminated
- 2017-06-09
- 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 restarting the RTCS) you should manually remove the patient from the couch before restarting the system. A software patch to address this issue is planned for early 2016. In the meantime please practice our recommendation of removing the patient from the couch prior to restarting the RTCS. If you have any questions or concerns regarding this issue, please do not hesitate to contact ViewRay Customer Support at support@viewray.com or call the ViewRay Customer Support center at 855-286-8875.
- Quantity
- 4 units
- Distribution
- US Distribution to the states of : CA, MO and WI., and Internationally to Korea.
- Lot, serial or model codes
- Catalog/Part Number: 10000; Serial Numbers: 100, 101, 102, & 105
- 510(k) numbers
- ["K111862"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 3007546534
- Firm city
- Oakwood Village
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28