Medical device recalls Moderate risk

Viewray Incorporated recalls MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.

Recall date
December 24, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0806-2016
FDA classification
Class II
Brand / firm
Viewray Incorporated
Sold / distributed
US Distribution to the states of : CA, FL, MO & WI., and Internationally to Republic of Korea.

Why it was recalled

The system loaded a completion fraction in the incorrect order after a treatment interruption.

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 Inc.

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