Use caution Medical device recall · FDA · Published April 20, 2022

Ion Beam Applications Proteus235 Proton Therapy System Recall: Incorrect Dose Risk

Ion Beam Applications recalls Proteus235 Proton Therapy System due to potential incorrect radiation dose delivery. Affected units have specific serial numbers and were sold in US/EU. Contact for remedy.

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

🇺🇸 FDA recall #Z-1205-2022Medical device Ion Beam Applications ›

Use caution until it’s fixed

First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the irradiated area may receive more dose than prescribed

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Ion Beam Applications is recalling its Proteus23:5 Proton Therapy System because the first layer of radiation treatment fields may receive more radiation than prescribed. This could lead to unintended tissue damage during cancer treatment. Read more at govinfonow.com/recall/60792-ion-beam-applications-proteus235-proton-therapy-system-recall-incorrect-dose.

Source Summary by GovInfoNow · govinfonow.com/recall/60792-ion-beam-applications-proteus235-proton-therapy-system-recall-incorrect-dose · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1205-2022

Cite this page

“Ion Beam Applications Proteus235 Proton Therapy System Recall: Incorrect Dose Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60792-ion-beam-applications-proteus235-proton-therapy-system-recall-incorrect-dose. Based on FDA recall #Z-1205-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1205-2022%22&limit=1).

Ion Beam Applications S.A. recalled its Proteus235- Proton Therapy System on April 20, 2022, according to the FDA. The device may deliver an incorrect proton beam dose due to scanning magnet setpoint errors.

How to tell if you have it

Brand: Ion Beam Applications
Product: Proteus235- Proton Therapy System
UPC: 05404013801138
Serial Numbers: PAT108 (US), PAT112 (US), SAT116 (US), PAT107 (EU)
Distribution: Worldwide, including IL, VA, WA, and Germany

The hazard

The first layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints. This results in a field size smaller than expected and the irradiated area receiving more dose than prescribed.

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 Systems: Positioning Software Anomaly Risk (2026-02-06) and RayStation/RayPlan 10B Software Recall (2025-11-28).

How to tell if you have this one

Check for serial numbers: PAT108, PAT112, SAT116 in the US and PAT107 in the EU. The system is used for proton therapy on localized tumors.

Brand
Ion Beam Applications
Product
Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Serial Numbers
Look for serial numbers PAT108, PAT112, SAT116 in the US or PAT107 in the EU on the device.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 3 states.

FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of IL, VA, WA and the country of Germany.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Illinois, Virginia, Washington.

Recall timeline

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

Apr 20, 2022Firm started the recall
May 27, 2022FDA classified it Class II
Jun 8, 2022Published in FDA’s Enforcement Report

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

Similar recalls

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Keep exploring

More Ion Beam Applications recalls

Link to this recall

<a href="https://govinfonow.com/recall/60792-ion-beam-applications-proteus235-proton-therapy-system-recall-incorrect-dose">Ion Beam Applications Proteus235 Proton Therapy System Recall: Incorrect Dose 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-1205-2022 (April 20, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1205-2022 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.