FDA Medical Device Recalls (openFDA)
Viewray, Inc.: MRIdian Linac Radiation Therapy System, Model 20000.
- Recall number
- Z-1251-2019
- Recalling firm
- Viewray, Inc.
- Product
- MRIdian Linac Radiation Therapy System, Model 20000.
- Status
- Terminated
- Initiated
- 2019-03-18
- Posted
- not on file
- Terminated
- 2022-06-16
- Reason
- A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur.
- Root cause
- Software design
- Action
- An undated letter was issued via email to customers on 3/18/2019, except for one customer who was issued the letter on 3/26/2019.
- Quantity
- 17 devices
- Distribution
- Distribution was made to FL, IL, MI, MO, NY, and WI. There was no government/military distribution. Foreign distribution was made to Denmark, France, Germany, Netherlands, South Korea, Switzerland, Turkey, UAE,
- Lot, serial or model codes
- Serial Numbers 101,107, 201, 202, 203, 204, 205, 206, 209, 211, 213, 214, 217, 221, 223, 225, 228.
- 510(k) numbers
- ["K170751"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 3011233554
- Firm city
- Mountain View
- Firm state
- CA
- 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