Use caution Medical device recall · FDA · Published July 10, 2024

Ion Beam Applications PROTEUS 235 Proton Therapy System Recall: Collision Detection Issues

Ion Beam Applications recalls PROTEUS 235 proton therapy systems due to temporary collision detection deactivation. Affected units may require repair to prevent safety risks during patient treatment.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2693-2024Medical device Ion Beam Applications ›

Use caution until it’s fixed

Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues

Take action

Contact the company

Recalling firmIon Beam Applications S.A.Chemin Du Cyclotron 3 · Ottignies-Louvain-La-Neuve, Belgium

✎ GovInfoNow plain-language explainer

Ion Beam Applications is recalling its PROTEUS 235 proton therapy systems because the Forte Robotic Patient Positioning System occasionally has issues with collision detection. This could lead to safety risks during patient treatments if not fixed. Read more at govinfonow.com/recall/54672-ion-beam-applications-proteus-235-proton-therapy-system-recall-collision.

Source Summary by GovInfoNow · govinfonow.com/recall/54672-ion-beam-applications-proteus-235-proton-therapy-system-recall-collision · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2693-2024

Cite this page

“Ion Beam Applications PROTEUS 235 Proton Therapy System Recall: Collision Detection Issues.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54672-ion-beam-applications-proteus-235-proton-therapy-system-recall-collision. Based on FDA recall #Z-2693-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2693-2024%22&limit=1).

Ion Beam Applications S.A. recalled IBA Proton Therapy System - PROTEUS 235 units due to temporary deactivation of collision detection for its Forte Robotic Patient Positioning System, the FDA said on July 10, 2024.

How to tell if you have it

IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients
UPC: 05404013801138
Serial Numbers: PAT.108 (US), PAT.110 (US), PAT.111 (FR), PAT.112 (US), PAT.113 (US), PAT.114 (CZ), PAT.115 (IT), SAT.116 (US), SAT.117 (PL), SAT.118 (RU), SAT.119 (US), SAT.120 (DE), SAT.122 (SE), SAT.123 (US), SAT.126 (US), SBF.101 (FR), SBF.103 (JP), SBF.104 (JP), SBF.105(US)

The hazard

The Forte Robotic Patient Positioning System occasionally experiences issues with the temporary deactivation of collision detection, according to the FDA.

Context

GovInfoNow's records show Ion Beam Applications S.A. has 21 other recalls on record since 2017-10-17. Other recent recalls of similar products include IBA Proton Therapy System PROTEUS 235 Recall: Risk of Mistreatment Without Safety Check (2026-02-03), Ion Beam Applications Recalls Proton Therapy Systems Due to Safety Mechanism Deactivation (2024-07-08), and Ion Beam Applications PROTEUS 235 Proton Therapy System Recall: Irradiation Risk (2024-05-10). Other recent recalls of similar products include Hitachi Proton Beam Therapy Systems: Positioning Software Anomaly Risk (2026-02-06), Hitachi Proton Beam Therapy System Recall: Positioning Software Anomaly Risk (2026-02-06), and GE Medical Systems Israel: Nuclear Medicine Systems with Potential Detector Fall Risk (2025-12-10).

How to tell if you have this one

Check for the PROTEUS 235 system with the UDI-DI: (01)05404013801138 and specific serial numbers listed in the recall notice. The system is designed for proton beam treatment of tumors and other conditions.

Brand
Ion Beam Applications
Product
IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Contact Manufacturer
Reach out to Ion Beam Applications to confirm if your system is affected and get instructions for next steps.

Where it went and when

Where it was distributed

Distributed in 9 states, and outside the U.S.

FDA distribution: “IL,LA, NJ, MI,OK, TN, TX, VA, WA Foreign: Czech Republic France Germany Italy Japan Poland Russia Sweden” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Illinois, Louisiana, Michigan, New Jersey, Oklahoma, Tennessee, Texas, Virginia, Washington.

Recall timeline

FDA published this recall 49 days after the firm started it.

Jul 10, 2024Firm started the recall
Aug 21, 2024FDA classified it Class II
Aug 28, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

More Ion Beam Applications recalls

Link to this recall

<a href="https://govinfonow.com/recall/54672-ion-beam-applications-proteus-235-proton-therapy-system-recall-collision">Ion Beam Applications PROTEUS 235 Proton Therapy System Recall: Collision Detection Issues (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2693-2024 (July 10, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2693-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.