FDA-Device2022-06-08Class II
Proteus235- Proton Therapy System: 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
First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the irradiated area may receive more dose than prescribed
Sold states
Worldwide distribution - US Nationwide distribution in the states of IL, VA, WA and the country of Germany.
Affected count
4 units
Manufactured in
3 Chemin Du Cyclotron, N/A, Louvain-la-neuve, N/A, Belgium
Products
Proteus235- Proton Therapy System: 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-1205-2022Don't want to check this manually?
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