FDA-Device2024-06-12Class II
IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Ion Beam Applications S.A.
Hazard
Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances
Sold states
Worldwide - US Nationwide distribution in the state of Virginia and the country of India.
Affected count
2 units
Manufactured in
Chemin Du Cyclotron 3, N/A, Ottignies-Louvain-La-Neuve, N/A, Belgium
Products
IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1945-2024Don't want to check this manually?
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