Ion Beam Applications S.A. recalls Proteus 235 Product Usage: The Proton Therapy System - P
Recalled Product
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.
Hazard / Issue
There is a risk of detachment of the Compact Gantry Rolling Floor.
Issued by
FDA
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