Medical device recalls Moderate risk

Viewray Incorporated recalls ViewRay System, Radiation Therapy System

Recall date
January 15, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1580-2015
FDA classification
Class II
Brand / firm
Viewray Incorporated
Sold / distributed
US distribution to MO.

Why it was recalled

The software was not correctly using the RT (Radiation Therapy) to MR (Magnetic Resonance image) coordinate correction for non HFS (Head First Supine) patient orientations, resulting in slice mismatch error.

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

What was recalled

ViewRay System, Radiation Therapy System

Get recall alerts

Free email alert whenever Viewray Incorporated has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Viewray Incorporated