FDA Medical Device Recalls (openFDA)
Viewray Incorporated: Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
- Recall number
- Z-2085-2015
- Recalling firm
- Viewray Incorporated
- Product
- Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
- Status
- Terminated
- Initiated
- 2015-04-01
- Posted
- 2015-07-16
- Terminated
- 2016-02-04
- Reason
- ViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot.
- Root cause
- Software Design Change
- Action
- ViewRay sent a Customer Advisory Notification Letters dated April 1, 2015 to thier customers. The letter identified the affected product, problem and actions to be taken. For questions or concerns regarding this issue, contact ViewRaylM Customer Support at support@viewray.com or call the ViewRaylM Customer Support center at 855-286-8875.
- Quantity
- 3
- Distribution
- US Nationwide Distribution in the states of CA, MO & WI
- Lot, serial or model codes
- Model #10000, Serial #'s: 100, 101, and 102
- 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