Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1945-2024 — 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.

U.S. FDA — Device Enforcement · Belgium · 2024-05-10 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1945-2024
Date of alert: 2024-05-10
Country / jurisdiction: Belgium
Risk level: Class II
Risk type: recall
Brand: Ion Beam Applications S.A.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 05404013814015

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-1945-2024 — 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.

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