Ion Beam Applications S.A. recalls Proteus 235, Uniform and Pencil Beam Scanning The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Pr…

Recall date

December 5, 2017

Source

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

Recall number

Z-0934-2018

FDA classification

Class II

Brand / firm

Ion Beam Applications S.A.

Sold / distributed

US Distribution to the states of : MA, FL, VA, PA, OK, TN

Why it was recalled

An accessory (range shifter, ridge filter&) can be improperly inserted in snout 300x400 with one rail only and the proton therapy system can still operate.

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, Uniform and Pencil Beam Scanning 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.