Use caution Medical device recall · FDA · Published December 12, 2018

Proteus 235 Proton Therapy System Recall: Risk of Gantry Floor Detachment

Ion Beam Applications S.A. recalls Proteus 235 proton therapy systems due to risk of Compact Gantry Rolling Floor detachment. Affected models include Proteus Plus and Proteus ONE. Consumers should contact the manufacturer for details.

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

🇺🇸 FDA recall #Z-0698-2019Medical device Ion Beam Applications S.A. ›

Use caution until it’s fixed

There is a risk of detachment of the Compact Gantry Rolling Floor.

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 S.A. recalls their Proteus 235 proton therapy systems (sold as Proteus Plus and Proteus ONE) because a part could detach. This could cause injury if the detached part moves unexpectedly during treatment. Read more at govinfonow.com/recall/69345-proteus-235-proton-therapy-system-recall-risk-of-gantry-floor.

Source Summary by GovInfoNow · govinfonow.com/recall/69345-proteus-235-proton-therapy-system-recall-risk-of-gantry-floor · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0698-2019

Cite this page

“Proteus 235 Proton Therapy System Recall: Risk of Gantry Floor Detachment.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69345-proteus-235-proton-therapy-system-recall-risk-of-gantry-floor. Based on FDA recall #Z-0698-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0698-2019%22&limit=1).

The FDA announced on 2018-12-12 that Ion Beam Applications S.A. is recalling the Proteus 235 Proton Therapy System (including Proteus Plus and Proteus ONE) due to a risk of detachment of the Compact Gantry Rolling Floor.

How to tell if you have it

Proteus 235 Proton Therapy System
Proteus Plus
Proteus ONE
SAT.123
SBF.101
SBF.103
SBF.104
SBF.105
SBF.107
SBF.109

The hazard

According to the FDA, there is a risk of detachment of the Compact Gantry Rolling Floor.

Context

GovInfoNow's records show Ion Beam Applications S.A. has had 21 other recalls on record since 2017-10-17. Other recent recalls of similar products include Hitachi Proton Beam Therapy Systems: Positioning Software Anomaly Risk (2026-02-06) and GE Maxxus Nuclear Medicine Systems Recall: Risk of Detector Fall Injury (2025-12-10).

How to tell if you have this one

Check if your medical facility uses the Proteus 235 system, which is sold under brand names Proteus Plus and Proteus ONE. The system is used for proton therapy treatments for localized tumors.

Brand
Ion Beam Applications S.A.
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Contact Manufacturer
Reach out to Ion Beam Applications S.A. for specific instructions on how to verify if your system is affected and what actions to take.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 2 states.

FDA distribution: “Worldwide Distribution - US Nationwide in the states of LA and MI. Foreign distribution to France, Japan, and UK.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Louisiana, Michigan.

Recall timeline

FDA terminated this recall 16 months after the firm started it.

Dec 12, 2018Firm started the recall
Jan 8, 2019FDA classified it Class II
Jan 16, 2019Published in FDA’s Enforcement Report
Apr 15, 2020FDA terminated the recall

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 S.A. recalls

Link to this recall

<a href="https://govinfonow.com/recall/69345-proteus-235-proton-therapy-system-recall-risk-of-gantry-floor">Proteus 235 Proton Therapy System Recall: Risk of Gantry Floor Detachment (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-0698-2019 (December 12, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0698-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.