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

Recall Z-2715-2020 — Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device 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 · 2020-07-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2715-2020
Date of alert: 2020-07-17
Country / jurisdiction: Belgium
Risk level: Class II
Risk type: recall
Brand: Ion Beam Applications S.A.
Product category: device
Product type: Devices

Reported risk: IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded.

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-2715-2020 — Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device 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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