FDA-Device2024-08-28Class 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

Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues

Sold states
IL,LA, NJ, MI,OK, TN, TX, VA, WA Foreign: Czech Republic France Germany Italy Japan Poland Russia Sweden
Affected count
19 units
Manufactured in
Chemin Du Cyclotron 3, Ottignies-Louvain-La-Neuve, 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-2693-2024

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