Use caution Medical device recall · FDA · Published May 26, 2021

Ion Beam Applications Proteus 235-Proton Therapy System Recall: Risk of Incorrect

Ion Beam Applications recalls Proteus 235-Proton Therapy Systems with specific serial numbers due to risk of incorrect radiation delivery if trigger input is forgotten during treatment. Affected units include PAT.107 through SAT.133 across multiple regions.

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

🇺🇸 FDA recall #Z-2155-2021Medical device Ion Beam Applications ›

Use caution until it’s fixed

if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated as prescribed, the treatment field may be delivered with an error in position

Take action

Contact the company

Recalling firmIon Beam Applications S.A.Chemin Du Cyclotron 3 · Louvain-la-neuve, Belgium

✎ GovInfoNow plain-language explainer

Ion Beam Applications is recalling specific models of their Proteus 235-Proton Therapy System. If users forget to manually select the trigger input during beam gating, the treatment may be delivered incorrectly, potentially causing harmful radiation exposure to the patient. Read more at govinfonow.com/recall/62474-ion-beam-applications-proteus-235-proton-therapy-system-recall-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/62474-ion-beam-applications-proteus-235-proton-therapy-system-recall-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2155-2021

Cite this page

“Ion Beam Applications Proteus 235-Proton Therapy System Recall: Risk of Incorrect.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62474-ion-beam-applications-proteus-235-proton-therapy-system-recall-risk. Based on FDA recall #Z-2155-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2155-2021%22&limit=1).

The FDA announced on May 26, 2021, that Ion Beam Applications S.A. is recalling its Proteus 235-Proton Therapy Systems due to a hazard where proton irradiation may be delivered without gating if the user forgets to manually select the trigger input. This error could result in the treatment field being delivered with a position error.

How to tell if you have it

Brand: Ion Beam Applications
Product: Proteus 235-Proton Therapy System
Serial Numbers: PAT.107 (EU), PAT.108 (US), PAT.109 (US), PAT.115 (EU), SAT.117 (EU), SAT.118 (RU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.125 (IN), SAT.126 (US), SAT.132 (EU), SAT.133 (US)
Distribution: FL, PA, TN, TX, VA; Germany, Italy, Russia, Sweden, India, Netherlands

The hazard

According to the FDA, if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated as prescribed, the treatment field may be delivered with an error in position.

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 (2026-02-03), Ion Beam Applications PROTEUS 235 Proton Therapy System Recall (2024-07-10), and Ion Beam Applications Recalls Proton Therapy Systems Due to Safety Mechanism Deactivation (2024-07-08). Other recent recalls of similar products include Hitachi Proton Beam Therapy System Recall (2026-02-06) and RayStation/RayPlan 10B Software Recall (2025-11-28).

How to tell if you have this one

Check the serial number on your Proteus 235-Proton Therapy System. Affected units include PAT.107 (EU), PAT.108 (US), PAT.109 (US), and other 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 Serial Number
Identify your system's serial number to determine if it is in the affected list: PAT.107 (EU), PAT.108 (US), PAT.109 (US), SAT.117 (EU), SAT.118 (RU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.125 (IN), SAT.126 (US), SAT.132 (EU), SAT.133 (US).

Where it went and when

Where it was distributed

Distributed in 5 states, and outside the U.S.

FDA distribution: “FL, PA, TN, TX, VA Foreign: Germany, Italy, Russia, Sweden , India, Netherlands” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Florida, Pennsylvania, Tennessee, Texas, Virginia.

Recall timeline

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

May 26, 2021Firm started the recall
Jul 28, 2021FDA classified it Class II
Aug 4, 2021Published 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/62474-ion-beam-applications-proteus-235-proton-therapy-system-recall-risk">Ion Beam Applications Proteus 235-Proton Therapy System Recall: Risk of Incorrect (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-2155-2021 (May 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2155-2021 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.