UnratedMedical device recall · FDA · Published October 19, 2017
Proteus 235 Proton Therapy System Recall: Range Variability in Radiation Treatment
Ion Beam Applications S.A. recalls Proteus 235 proton therapy systems due to potential range variability in radiation treatment planning. This may affect treatment accuracy for patients with localized tumors.
“Proteus 235 Proton Therapy System Recall: Range Variability in Radiation Treatment.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/72780-proteus-235-proton-therapy-system-recall-range-variability-in-radiation. Based on FDA recall #Z-0931-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0931-2018%22&limit=1).
Ion Beam Applications S.A. recalled Proteus 235 proton therapy systems with Pencil Beam Scanning version PTS-6.4.11.X on Oct. 19, 2017, according to the FDA. The agency announced the Class II recall due to potential range discrepancies in irradiation plans.
How to tell if you have it
Brand: Ion Beam Applications S.A.
Product: Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X
Brand names: Proteus Plus and Proteus ONE
Quantity: 3 units
Distribution: Florida
The hazard
The hazard involves the range for the same energy being different depending on whether the layer is the first layer of the irradiation plan, according to the FDA.
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 Hitachi Proton Beam Therapy Systems: Positioning Software Anomaly Risk (Feb. 6, 2026) and RayStation/RayPlan Software Recall: Radiation Dose Calculation Errors (Nov. 28, 2025).
How to tell if you have this one
The Proteus 235 system with Pencil Beam Scanning version PTS-6.4.11.X is a medical device for proton therapy. It may be marketed under brand names Proteus Plus or Proteus ONE.
Brand
Ion Beam Applications S.A.
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify if your device has the Proteus 235 model with Pencil Beam Scanning version PTS-6.4.11.X or brand names Proteus Plus or Proteus ONE.
Where it went and when
Where it was distributed
Distributed in Florida.
Listed by the agency
Not listed
FDA distribution: “US Distribution to the state of :FL” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida.
Recall timeline
FDA terminated this recall 17 months 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-0931-2018 (October 19, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0931-2018 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.