Ion Beam Applications S.A. recalls Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X The Proton Therapy System - Proteus 235 (brand names: Proteus Pl…

Recall date

October 19, 2017

Source

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

Recall number

Z-0931-2018

FDA classification

Class II

Brand / firm

Ion Beam Applications S.A.

Sold / distributed

US Distribution to the state of :FL

Why it was recalled

Range for the same energy could be different depending if the layer is the first layer of the irradiation plan or not.

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, Pencil Beam Scanning version PTS-6.4.11.X 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.