Viewray Incorporated recalls MRIdian¿ ViewRay¿ Radiation Therapy System, ViewRay¿ Is indicated for stereotactic radiosurgery and precision radiother…

Recall date

August 27, 2015

Source

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

Recall number

Z-0115-2016

FDA classification

Class II

Brand / firm

Viewray Incorporated

Sold / distributed

US Distribution to the states of : CA, MO and WI., and Internationally to Korea.

Why it was recalled

ViewRay discovered that in the event that an encoder breaks or fails on the Patient Handling System (PHS, or couch), when attempting to restart the system, the couch could move unexpectedly.

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¿ Is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.