Use cautionMedical device recall · FDA · Published January 26, 2018
Proteus 235/PLUS/ONE Proton Therapy Devices: Risk of Under-Irradiation or Delayed
Ion Beam Applications recalls Proteus 235, ProteusPLUS, and Proteus ONE proton therapy devices with PTS-7.X.X or PTS-8.X.X software versions. Switching treatment modes may cause under-irradiation or delayed patient treatment with extra X-ray exposure.
When switching from Pencil Beam Scanning treatment mode to Uniform Scanning treatment mode, the tuning setpoints of the scanning magnets are not always taken into account when the proton beam is requested. The mismatch between the setpoint and feedback leads to an error message. Depending on user action, two scenarios are possible: 1. The user resumes the treatment field without analyzing the cause for the error message. This may lead to under-irradiation. 2. The user reboots the Scanning Magnets Power Supply Electronic Unit. This may lead to delay in patient treatment and the patient may need to be re-aligned, which leads to an additional X-ray dose.
Take action
Contact the company
📍Recalling firmIon Beam Applications S.A.Chemin du Cyclotron, 3 · Louvain La Neuve, Belgium
“Proteus 235/PLUS/ONE Proton Therapy Devices: Risk of Under-Irradiation or Delayed.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72090-proteus-235-plus-one-proton-therapy-devices-risk-of-under. Based on FDA recall #Z-1477-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1477-2018%22&limit=1).
The FDA announced on Jan. 26, 2018, that Ion Beam Applications S.A. is recalling Proteus 235, ProteusPLUS, and Proteus ONE proton therapy systems due to potential under-irradiation or additional X-ray exposure. The agency classified the recall as Class II.
How to tell if you have it
Brand: Ion Beam Applications
Models: Proteus 235, ProteusPLUS, Proteus ONE
Versions: PTS-7.X.X and PTS-8.X.X
Serial numbers: PAT.107 (EU); PAT.108, PAT.112, PAT.113, PAT.116 (US)
Quantity: 5 units
The hazard
According to the FDA, switching from Pencil Beam Scanning to Uniform Scanning mode may cause scanning magnet tuning setpoints to be ignored, leading to error messages. If users resume treatment without analyzing the error, it may lead to under-irradiation. Alternatively, rebooting the power supply electronic unit may delay treatment and require patient re-alignment, resulting in an additional X-ray dose.
Context
GovInfoNow's records show Ion Beam Applications S.A. has 21 other recalls on record since Oct. 17, 2017. Other recent recalls of similar products include IBA Proton Therapy System PROTEUS 235 Recall: Risk of Mistreatment Without Safety Check (Feb. 3, 2026), Ion Beam Applications PROTEUS 235 Proton Therapy System Recall: Collision Detection Issues (July 10, 2024), and Ion Beam Applications Recalls Proton Therapy Systems Due to Safety Mechanism Deactivation (July 8, 2024). Other recent recalls of similar products include Hitachi Proton Beam Therapy Systems: Positioning Software Anomaly Risk (Feb. 6, 2026) and RayStation/RayPlan Software 11A Recalls: Radiation Dose Calculation Risk (Nov. 28, 2025).
How to tell if you have this one
Check for software versions PTS-7.X.X or PTS-8.X.X. Affected devices include Proteus 235, ProteusPLUS, and Proteus ONE with serial numbers PAT.107 (EU), PAT.108, PAT.112, PAT.113, PAT.116 (US).
Brand
Ion Beam Applications
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your device has PTS-7.X.X or PTS-8.X.X software versions to determine if it's affected.
Review Error Messages
If an error message appears when switching treatment modes, do not resume treatment without analyzing the cause.
Reboot System if Needed
If the error message persists, reboot the Scanning Magnets Power Supply Electronic Unit to avoid treatment delays.
Where it went and when
Where it was distributed
Distributed in 4 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “Consignees in four states: VA, IL, NJ, and WA. One consignee located in Germany.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Illinois, New Jersey, Virginia, Washington.
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-1477-2018 (January 26, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1477-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 31, 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.