Viewray Incorporated recalls Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and preci…

Recall date

May 7, 2015

Source

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

Recall number

Z-1954-2015

FDA classification

Class II

Brand / firm

Viewray Incorporated

Sold / distributed

Distributed in the states of CA, MO & WI.

Why it was recalled

The software was failing to determine new patient locations if imaging is not enabled during treatment.

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

What was recalled

Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.