FDA Medical Device Recalls (openFDA)
Viewray Incorporated: Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
- Recall number
- Z-1954-2015
- Recalling firm
- Viewray Incorporated
- Product
- Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
- Status
- Terminated
- Initiated
- 2015-05-07
- Posted
- 2015-07-02
- Terminated
- 2016-02-04
- Reason
- The software was failing to determine new patient locations if imaging is not enabled during treatment.
- Root cause
- Software design
- Action
- On May 7, 2015 the firm sent Customer Advisory Notification Letters to their customers.
- Quantity
- 3
- Distribution
- Distributed in the states of CA, MO & WI.
- Lot, serial or model codes
- Catalog/Part Number: 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