FDA Medical Device Recalls (openFDA)
Viewray, Inc.: ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software
- Recall number
- Z-1803-2020
- Recalling firm
- Viewray, Inc.
- Product
- ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software
- Status
- Terminated
- Initiated
- 2019-11-18
- Posted
- not on file
- Terminated
- 2023-02-22
- Reason
- Registering dose and structures in the treatment delivery workflow could result in an alignment discrepancy between the imported previously delivered dose and the displayed patient anatomy and structures. The MRIdian TPDS software shows this misalignment to the user in the predicted dose-volume histogram (DVH). The misalignment impact may not be obvious to the user. During plan re-optimization the previously delivered dose would be incorrectly accounted for by the software. This may result in unexpectedly higher or lower dose than the intended dose calculated for the subsequent treatment plan. When this occurs in the treatment planning workflow, the registration fails to align the dose with the image and the user is unable to proceed.
- Root cause
- Software design
- Action
- On 11/18/2019, the firm send an "Urgent Device Correction" letter to customers via email to inform them firm has become aware of an issue impacting the MRIdian System Treatment Planning and Delivery System (TPDS) software. The issue relates to an optional feature related to using previously delivered dose to make a new plan on MRIdian. The firm determined that in some cases dose previously delivered to a patient may not be accurately registered with a daily scan. The firm is instructing its customers to: 1) Do not: Sum previously delivered treatment plans in the treatment delivery workflow as it could result in delivery of a higher or lower dose. 2) Do not: proceed with plan summation if this issue is observed in planning workflow. 3) Do: contact ViewRay Customer Support for assistance when summing plans in the treatment planning workflow. ViewRay is developing a resolution for this issue. You will be contacted by VewRay Customer Support when a software resolution is available. If you have any questions, please do not hesitate to contact ViewRay Customer Support at support@viewray.com or call +1 855-286-8875.
- Quantity
- 32
- Distribution
- Worldwide distribution. US states of MO, WI, CA, FL, MI, NY, MI, IL, and MA. South Korea, Netherlands, Italy, Japan, Germany, UAE, Turkey, France, Israel, Denmark, Switzerland, and United Kingdom. The distributors are assigned to applicable regions. Firm send the Urgent Device Corrections to them and they forwarded them to the sites.
- Lot, serial or model codes
- Model No.10000 - Serial No's:. 100,104,105,112,113 Model No. 20000 - Serial No's: 101,102,107,108,200,201,203,204,206,207,209,211, 213,214,215,216,217,218,221,223,225,227,228,232,238,240,243, 244,247,250
- 510(k) numbers
- ["K111862","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