Viewray Incorporated recalls MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the MRIdian¿ Sy…

Recall date

March 7, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1309-2016

FDA classification

Class II

Brand / firm

Viewray Incorporated

Sold / distributed

Worldwide Distribution - US including CA, FL, MO & WI., and International distribution to the Republic of Korea and The Netherlands.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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