FDA Medical Device Recalls (openFDA)
Viewray, Inc.: ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiation with photon beams and delivering stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated, in conjunction with the ViewRay System, an MRI image-guided radiation therapy system.
- Recall number
- Z-1836-2021
- Recalling firm
- Viewray, Inc.
- Product
- ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiation with photon beams and delivering stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated, in conjunction with the ViewRay System, an MRI image-guided radiation therapy system.
- Status
- Terminated
- Initiated
- 2021-05-04
- Posted
- not on file
- Terminated
- 2023-10-19
- Reason
- Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software.
- Root cause
- Software design
- Action
- On May 2021, ViewRay issued an "Urgent Medical Device Correction" notification to all affected consignees via E-Mail. All affected consignees were outside of the US. In addition to informing consignees about the recall, ViewRay asked customers to take the following actions: 1. We will provide an update to customers when new information is available. Until that time: 2. Customers should be aware of these software anomalies and the behavior of the system described in this letter. 3. Please promptly complete and return the enclosed Customer Response Form to acknowledge receipt of this notification. 4. Any device-related incidents should be reported to ViewRay, ViewRays distributor or local representative. Adverse reactions or quality problems experienced with the use of this product may be reported to the Competent Authority if appropriate or to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax. 5. If you have any questions related to this letter, please contact ViewRay Customer Support at support@viewray.com or call +1 855-286-8875 toll free 24 hours a day, 7 days a week.
- Quantity
- 8 versions
- Distribution
- International distribution only to the countries of France, Germany, Italy, and Switzerland.
- Lot, serial or model codes
- French version of the TDS software affected serial numbers: 214, 215, 226 and 240 German or Italian versions of the TDS software affected serial numbers: 203, 232, 108 and 244
- 510(k) numbers
- ["K102915","K181989"]
- PMA numbers
- not on file
- Product code
- MUJ
- 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