Ion Beam Applications S.A.: Device Recall

Recall #Z-2693-2024 · 07/10/2024

Class II: Risk

Recall Details

Recall Number
Z-2693-2024
Classification
Class II
Product Type
Device
Recalling Firm
Ion Beam Applications S.A.
Status
Ongoing
Date Initiated
07/10/2024
Location
Ottignies-Louvain-La-Neuve, Belgium
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
19 units

Reason for Recall

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

Product Description

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

Distribution Pattern

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

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.