Ion Beam Applications S.A. recalls Proteus 235 Product Usage: The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a med…

Recall date

December 12, 2018

Source

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

Recall number

Z-0698-2019

FDA classification

Class II

Brand / firm

Ion Beam Applications S.A.

Sold / distributed

Worldwide Distribution - US Nationwide in the states of LA and MI. Foreign distribution to France, Japan, and UK.

Why it was recalled

There is a risk of detachment of the Compact Gantry Rolling Floor.

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 Product Usage: The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) 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.