Class II

Medical Device Recall: 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. · May 10, 2024

Reason for Recall

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

Distribution

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

States Affected

NATIONWIDE

Quantity Affected

2 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1945-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.