Viewray, Inc. ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software
Brand
Viewray, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
Viewray, Inc. is recalling ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatmen due to Registering dose and structures in the treatment delivery workflow could result in an alignment discrepancy between the imported previously delivered . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL, IL, MA, MI, MO, NY, WI
Page updated: Jan 10, 2026