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Ion Beam Applications S.A. recalls The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management Sys
Recalled July 4, 2018 · FDA recall Z-2284-2018 · Ion Beam Applications S.A
Hazard
IBA is conducting a voluntary recall to address a PTS (Proton Therapy System) software issue and to reduce the risk related to this issue. · FDA Class II
Units
2
Sold at
Units were distributed to Korea and Jacksonville, FL.
Description
IBA is conducting a voluntary recall to address a PTS (Proton Therapy System) software issue and to reduce the risk related to this issue.
Product
The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS)
Manufacturer(s)
Ion Beam Applications S.A.
Made in
Belgium
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →