FDA Medical Device Recalls (openFDA)
Viewray Incorporated: MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.
- Recall number
- Z-0806-2016
- Recalling firm
- Viewray Incorporated
- Product
- MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.
- Status
- Terminated
- Initiated
- 2015-12-24
- Posted
- 2016-02-12
- Terminated
- 2017-02-22
- Reason
- The system loaded a completion fraction in the incorrect order after a treatment interruption.
- Root cause
- Software design
- Action
- ViewRay sent an Customer Advisory Notice dated December 24, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Workaround: If you want to move a completion plan to a later date in the Delivery Calendar then do not schedule it until right before you are ready to treat that completion plan. While we will address this issue in the next release of software we recommend that in the event of a completion plan you always review the plan name loaded on the TPDS and verify the remaining time and beams are as expected with the completion plan. 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
- 5 units
- Distribution
- US Distribution to the states of : CA, FL, MO & WI., and Internationally to Republic of Korea.
- Lot, serial or model codes
- Model #: 10000, Serial #'s: 100, 101, 102, 104 & 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