Unrated Medical device recall · FDA · Published March 4, 2024

Ion Beam Applications PROTEUS 235 and PTS Models Recall: Safety Parameter Risk

Ion Beam Applications recalls specific proton therapy systems due to risk of safety parameters being out of tolerance during irradiation. Affected models include PROTEUS 235, PTS-10, PTS-11, and PTS-12 versions. No remedy is specified in the recall notice.

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

🇺🇸 FDA recall #Z-1603-2024Medical device Ion Beam Applications ›

Recall notice

There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.

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 specific versions of their proton therapy systems (PROTEUS 235, PTS-10, PTS-11, and PTS-12) because safety parameters may go out of tolerance during treatment, potentially allowing irradiation to occur when it should not. This could lead to unintended radiation exposure if the system is used without proper safety checks. Read more at govinfonow.com/recall/55995-ion-beam-applications-proteus-235-and-pts-models-recall-safety.

Source Summary by GovInfoNow · govinfonow.com/recall/55995-ion-beam-applications-proteus-235-and-pts-models-recall-safety · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1603-2024

Cite this page

“Ion Beam Applications PROTEUS 235 and PTS Models Recall: Safety Parameter Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/55995-ion-beam-applications-proteus-235-and-pts-models-recall-safety. Based on FDA recall #Z-1603-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1603-2024%22&limit=1).

The FDA announced on March 4, 2024, that Ion Beam Applications S.A. is recalling IBA Proton Therapy System - PROTEUS 235, PTS-10, PTS-11, and PTS-12 versions due to a risk of mistreatment if irradiation is not prevented when safety parameters are out of tolerance.

How to tell if you have it

Brand: Ion Beam Applications
Product: IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions
UDI-DI: 05404013801138
Serial Numbers: SAT.123, SAT.126, SAT.133, SAT.140, SBF.105, SBF.113, SBF.128, SBF.135
Units affected: 8 units

The hazard

The hazard involves a risk of mistreatment because irradiation is not prevented when some safety parameters are out of tolerance.

Context

GovInfoNow's records show Ion Beam Applications S.A. has 21 other recalls on record since October 17, 2017. Other recent recalls of similar products include IBA Proton Therapy System PROTEUS 235 Recall (February 3, 2026), Ion Beam Applications PROTEUS 235 Proton Therapy System Recall (July 10, 2024), Ion Beam Applications Recalls Proton Therapy Systems Due to Safety Mechanism Deactivation (July 8, 2024), RayStation/RayPlan Software 11A Recalls (November 28, 2025), RayStation/RayPlan 10B Software Recall (November 28, 2025), and Hitachi Proton Beam Therapy Systems (February 6, 2026).

How to tell if you have this one

Check for the model numbers PROTEUS 235, PTS-10, PTS-11, or PTS-12 on the device. Serial numbers include SAT.123, SAT.126, SAT.133, SAT.140, SBF.105, SBF.113, SBF.128, and SBF.135. All configurations of these models are affected.

Brand
Ion Beam Applications
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Model
Identify the model number on the device to see if it matches PROTEUS 235, PTS-10, PTS-11, or PTS-12.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 7 states.

FDA distribution: “US Nationwide distribution in the states of AR, FL, LA, KS, MI, TX, VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arkansas, Florida, Kansas, Louisiana, Michigan, Texas, Virginia.

Recall timeline

FDA published this recall 58 days after the firm started it.

Mar 4, 2024Firm started the recall
Apr 19, 2024FDA classified it Class II
May 1, 2024Published in FDA’s Enforcement Report

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

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Link to this recall

<a href="https://govinfonow.com/recall/55995-ion-beam-applications-proteus-235-and-pts-models-recall-safety">Ion Beam Applications PROTEUS 235 and PTS Models Recall: Safety Parameter Risk (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-1603-2024 (March 4, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1603-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.