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Ion Beam Applications S.A. recalls Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 is a medical device design
Recalled July 12, 2017 · FDA recall Z-2684-2017 · Ion Beam Applications S.A
Hazard
Software issue · FDA Class II
Units
6 worldwide and 5 in the U.S.
Sold at
Distributed to FL, VA, IL, NJ, WA and South Korea
Description
Software issue
Product
Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 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 →