Ion Beam Applications S.A. recalls Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 is a medical device designed…

Recall date

December 13, 2016

Source

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

Recall number

Z-2684-2017

FDA classification

Class II

Brand / firm

Ion Beam Applications S.A.

Sold / distributed

Distributed to FL, VA, IL, NJ, WA and South Korea

Why it was recalled

Software issue

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

What was recalled

Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.