FDA Medical Device Recalls (openFDA)
Viewray Incorporated: ViewRay System, Radiation Therapy System
- Recall number
- Z-1580-2015
- Recalling firm
- Viewray Incorporated
- Product
- ViewRay System, Radiation Therapy System
- Status
- Terminated
- Initiated
- 2015-01-15
- Posted
- 2015-05-05
- Terminated
- 2015-09-23
- Reason
- The software was not correctly using the RT (Radiation Therapy) to MR (Magnetic Resonance image) coordinate correction for non HFS (Head First Supine) patient orientations, resulting in slice mismatch error.
- Root cause
- Software Design Change
- Action
- On January 15, 2014, ViewRay personnel discussed the investigation of the issue (slice mismatch error) with the customer. The firm advised the customer that until the issue was corrected, to not treat patients in non HFS orientations, or to use the MR acquired from the ViewRay system as the primary plan series for non HFS scans. ViewRay installed software version 3.4.5.28 on January 20 and 21, 2014, in order to prevent this slice mismatch error from occurring in any patient position.
- Quantity
- 1
- Distribution
- US distribution to MO.
- Lot, serial or model codes
- M/N 10000, S/N 100 only
- 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