Ion Beam Applications S.A. recalls Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 The Proton Therapy System - Proteus 235 (brand names: Proteu…

Recall date

November 1, 2017

Source

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

Recall number

Z-0943-2018

FDA classification

Class II

Brand / firm

Ion Beam Applications S.A.

Sold / distributed

Worldwide Distribution: US (nationwide) to: MI only and country of: France.

Why it was recalled

The internal configuration of the electrometers and the Real-Time control boards of the Dekimo Scanning Controller is not checked before each patient treatment.

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, PTS-9.4.X, PTS-10.0.1.1 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.