Use caution Medical device recall · FDA · Published July 8, 2024

Ion Beam Applications Recalls Proton Therapy Systems Due to Safety Mechanism Deactivation

Ion Beam Applications recalls specific versions of their Proton Therapy System software due to potential safety parameter deactivation during clinical use. Affected units include ProteusPLUS and ProteusONE software versions PTS-8 through PTS-12.

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

🇺🇸 FDA recall #Z-3089-2024Medical device Ion Beam Applications ›

Use caution until it’s fixed

Safety Parameters Verification Mechanisms can be deactivated in clinical runtime

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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 System software (ProteusPLUS and ProteusONE) because safety mechanisms could be deactivated during clinical use. This could lead to unsafe conditions if the system is not properly monitored. Read more at govinfonow.com/recall/54690-ion-beam-applications-recalls-proton-therapy-systems-due-to-safety.

Source Summary by GovInfoNow · govinfonow.com/recall/54690-ion-beam-applications-recalls-proton-therapy-systems-due-to-safety · Updated August 19, 2026 · FDA enforcement record: FDA #Z-3089-2024

Cite this page

“Ion Beam Applications Recalls Proton Therapy Systems Due to Safety Mechanism Deactivation.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54690-ion-beam-applications-recalls-proton-therapy-systems-due-to-safety. Based on FDA recall #Z-3089-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3089-2024%22&limit=1).

The FDA announced on July 8, 2024, that Ion Beam Applications S.A. is recalling IBA Proton Therapy System software versions PTS-8 through PTS-12 due to a hazard where safety parameters verification mechanisms can be deactivated in clinical runtime.

How to tell if you have it

Brand: Ion Beam Applications
Product: IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions
UDI-DI: 05404013801138
Serial Numbers: PAT.107 (DE), PAT.108 (US), PAT.109 (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.125 (IN), SAT.126 (US), SAT.127 (TW), SAT.132 (NL), SAT.133 (US), SAT.136 (IN), SAT.140 (US), SBF.101 (FR), SBF.103 (JP), SBF.104 (JP), SBF.105 (US), SBF.107 (FR), SBF.112 (BE), SBF.113 (US), SBF.117 (ES), SBF.124 (IT), SBF.125 (SG), SBF.128 (US), SBF.135 (US)

The hazard

According to the FDA, the safety parameters verification mechanisms can be deactivated in clinical runtime for the recalled software versions.

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: Risk of Mistreatment Without Safety Check (February 3, 2026), Ion Beam Applications PROTEUS 235 Proton Therapy System Recall: Collision Detection Issues (July 10, 2024), and Ion Beam Applications PROTEUS 235 Proton Therapy System Recall: Irradiation Risk (May 10, 2024). Other recent recalls of similar products include Hitachi Proton Beam Therapy Systems: Positioning Software Anomaly Risk (February 6, 2026) and RayStation/RayPlan Software 11A Recalls: Radiation Dose Calculation Risk (November 28, 2025).

How to tell if you have this one

Check for software versions PTS-8 through PTS-12 in the ProteusPLUS and ProteusONE systems. Affected units have specific serial numbers listed in the recall notice.

Brand
Ion Beam Applications
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Identify the software version by checking the system's settings or documentation.
Contact Manufacturer
Reach out to Ion Beam Applications for guidance on whether your system is affected and next steps.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 11 states.

FDA distribution: “Worldwide - US Nationwide distribution in the states of AK, NJ, PA, VA,OK,FL, KA, IL, LA, MI, TN , TX, VA and the countries of BE, CZ, DE, ES, FR, IN, IT, JP, NL, PL, RU, SE, SG, TW.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alaska, Florida, Illinois, Louisiana, Michigan, New Jersey, Oklahoma, Pennsylvania, Tennessee, Texas, Virginia.

Recall timeline

FDA published this recall 2 months after the firm started it.

Jul 8, 2024Firm started the recall
Sep 10, 2024FDA classified it Class II
Sep 18, 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/54690-ion-beam-applications-recalls-proton-therapy-systems-due-to-safety">Ion Beam Applications Recalls Proton Therapy Systems Due to Safety Mechanism Deactivation (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-3089-2024 (July 8, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3089-2024 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.