Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
MRIdian ViewRay Radiation Therapy System Recalled by Viewray Incorporated Due to When editing the isocenter or the couch position...
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 Incorporated directly.
Affected Products
MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the MRIdian¿ System) is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated
Quantity: 5 units
Why Was This Recalled?
When editing the isocenter or the couch position of the plan while in the treatment workflow (in the Points screen) and re-optimizing, the software will not prompt the user to shift the couch to the new isocenter. As a result there is the potential to deliver dose to the initial isocenter rather than the new location.
Where Was This Sold?
This product was distributed to 4 states: CA, FL, MO, WI
About Viewray Incorporated
Viewray Incorporated 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