FDA-Device2018-07-04Class II
The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS)
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.
Sold states
Units were distributed to Korea and Jacksonville, FL.
Affected count
2
Manufactured in
Chemin du Cyclotron, 3, Louvain La Neuve, Belgium
Products
The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2284-2018Don't want to check this manually?
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