Ion Beam Applications S.A.: Device Recall

Recall #Z-3089-2024 · 07/08/2024

Class II: Risk

Recall Details

Recall Number: Z-3089-2024
Classification: Class II
Product Type: Device
Recalling Firm: Ion Beam Applications S.A.
Status: Ongoing
Date Initiated: 07/08/2024
Location: Ottignies-Louvain-La-Neuve, Belgium
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 35 units

Reason for Recall

Safety Parameters Verification Mechanisms can be deactivated in clinical runtime

Product Description

IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions

Distribution Pattern

Worldwide - US Nationwide distribution in the states of AK, NJ, PA, VA,OK,FL, KA, IL, LA, MI, TN , TX, VA and the countries of BE, CZ, DE, ES, FR, IN, IT, JP, NL, PL, RU, SE, SG, TW.

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 05/10/2024

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

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.