Ion Beam Applications S.A.: Device Recall

Recall #Z-1945-2024 · 05/10/2024

Class II: Risk

Recall Details

Recall Number: Z-1945-2024
Classification: Class II
Product Type: Device
Recalling Firm: Ion Beam Applications S.A.
Status: Ongoing
Date Initiated: 05/10/2024
Location: Ottignies-Louvain-La-Neuve, N/A, Belgium
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2 units

Reason for Recall

Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances

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

Worldwide - US Nationwide distribution in the state of Virginia and the country of India.

Other Recalls by Ion Beam Applications S.A.

Class II: Risk 07/10/2024

Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues
Class II: Risk 07/08/2024

Safety Parameters Verification Mechanisms can be deactivated in clinical runtime

View all recalls by Ion Beam Applications S.A. →

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.