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
FDA Recall Z-1309-2016 · Posted 2016-03-31
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Recalling FirmViewray Incorporated
Recall StatusTerminated
Product CodeIYE
Date Initiated2016-03-07
Date Terminated2017-02-22
Product Quantity5 units
Reason for Recall
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.
Firm Action
ViewRay sent an Urgent Device Correction letter dated March 7, 2016. The letter identified the product, the problem, and the action to be taken by the customer. Customers with questions were instructed to contact ViewRay Customer Support at [email protected] or call the ViewRay Customer Support center at 855-286-8875.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - US including CA, FL, MO & WI., and International distribution to the Republic of Korea and The Netherlands.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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