Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ViewRay System: Model No. 10000 and 20000 for radiation treatment. Recalled by Viewray, Inc. Due to Registering dose and structures in the treatment delivery...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Viewray, Inc. directly.
Affected Products
ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software
Quantity: 32
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 8 states: CA, FL, IL, MA, MI, MO, NY, WI
About Viewray, Inc.
Viewray, Inc. has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report