FDA recall Z-2693-2024

Ion Beam Applications S.A. · Class II · device

Product

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

Reason for recall

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

Distribution

IL,LA, NJ, MI,OK, TN, TX, VA, WA Foreign: Czech Republic France Germany Italy Japan Poland Russia Sweden

Key facts

Status
Ongoing
Initiation date
2024-07-10
Report date
2024-08-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Ottignies-Louvain-La-Neuve, Belgium

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2693-2024