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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
Recalled March 14, 2018 · FDA recall Z-0931-2018 · Ion Beam Applications S.A
Hazard
Range for the same energy could be different depending if the layer is the first layer of the irradiation plan or not. · FDA Class II
Units
3
Sold at
US Distribution to the state of :FL
Description
Range for the same energy could be different depending if the layer is the first layer of the irradiation plan or not.
Product
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.
Manufacturer(s)
Ion Beam Applications S.A.
Made in
Belgium
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →