Unrated Medical device recall · FDA · Published November 1, 2017

Proteus 235 Proton Therapy System Recall: Unchecked Electrometer Configuration Risk

Ion Beam Applications S.A. recalls Proteus 235 proton therapy systems due to unverified electrometer configuration before patient treatments. This could affect treatment accuracy and safety for cancer patients.

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

🇺🇸 FDA recall #Z-0943-2018Medical device Ion Beam Applications S.A. ›

Recall notice

The internal configuration of the electrometers and the Real-Time control boards of the Dekimo Scanning Controller is not checked before each patient treatment.

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 because the electrometers and control boards aren't checked before each patient treatment. This could lead to inaccurate radiation delivery during cancer treatments. Read more at govinfonow.com/recall/72639-proteus-235-proton-therapy-system-recall-unchecked-electrometer-configuration-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/72639-proteus-235-proton-therapy-system-recall-unchecked-electrometer-configuration-risk · Updated September 14, 2026 · FDA enforcement record: FDA #Z-0943-2018

Cite this page

“Proteus 235 Proton Therapy System Recall: Unchecked Electrometer Configuration Risk.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/72639-proteus-235-proton-therapy-system-recall-unchecked-electrometer-configuration-risk. Based on FDA recall #Z-0943-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0943-2018%22&limit=1).

The FDA announced on 2017-11-01 that Ion Beam Applications S.A. is recalling Proteus 235 proton therapy systems due to an unchecked internal configuration of electrometers and Real-Time control boards, according to the FDA.

How to tell if you have it

Proteus 235 (brand names: Proteus Plus and Proteus ONE)
Pencil Beam Scanning
PTS-9.4.X
PTS-10.0.1.1
SBF.101 (EU)
SBF.105 (US)

The hazard

The internal configuration of the electrometers and the Real-Time control boards of the Dekimo Scanning Controller is not checked before each patient treatment, according to the FDA.

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 Elekta MOSAIQ Oncology System Recall: Risk of Overtreatment in Particle Therapy (2025-12-10) and Hitachi Proton Beam Therapy Systems: Positioning Software Anomaly Risk (2026-02-06).

How to tell if you have this one

The Proteus 235 system with model numbers PTS-9.4.X or PTS-10.0.1.1 is recalled. It's used for proton therapy in medical facilities treating cancer patients.

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 guidance on the recall process.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide Distribution: US (nationwide) to: MI only and country of: France.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

Nov 1, 2017Firm started the recall
Mar 9, 2018FDA classified it Class II
Mar 21, 2018Published in FDA’s Enforcement Report
Mar 29, 2019FDA terminated the recall

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

Similar recalls

Latest medical device recalls

Keep exploring

More Ion Beam Applications S.A. recalls

Link to this recall

<a href="https://govinfonow.com/recall/72639-proteus-235-proton-therapy-system-recall-unchecked-electrometer-configuration-risk">Proteus 235 Proton Therapy System Recall: Unchecked Electrometer Configuration 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-0943-2018 (November 1, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0943-2018 to see it in context.
Plain-language summary written by qwen3:4b on September 14, 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.