Use cautionMedical device recall · FDA · Published December 5, 2017
Ion Beam Applications Proteus 235 Proton Therapy System Recall: Improper Accessory
Ion Beam Applications recalls Proteus 235 proton therapy systems due to risk of improper accessory insertion causing system operation without proper safety. Affected units may need verification and action.
An accessory (range shifter, ridge filter&) can be improperly inserted in snout 300x400 with one rail only and the proton therapy system can still operate.
Take action
Contact the company
📍Recalling firmIon Beam Applications S.A.Chemin du Cyclotron, 3 · Louvain La Neuve, Belgium
“Ion Beam Applications Proteus 235 Proton Therapy System Recall: Improper Accessory.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72392-ion-beam-applications-proteus-235-proton-therapy-system-recall-improper. Based on FDA recall #Z-0934-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0934-2018%22&limit=1).
Ion Beam Applications S.A. recalled Proteus 235, Uniform and Pencil Beam Scanning The Proton Therapy System - Proteus 235 medical devices on Dec. 5, 2017, according to the FDA. The hazard involves an accessory that can be improperly inserted in snout 300x400 with one rail only while the system still operates.
How to tell if you have it
Brand: Ion Beam Applications
Product names: Proteus 235, Uniform and Pencil Beam Scanning The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE)
Units affected: 14
The hazard
An accessory (range shifter, ridge filter&) can be improperly inserted in snout 300x400 with one rail only and the proton therapy system can still operate.
Context
GovInfoNow's records show Ion Beam Applications S.A. has had 21 other recalls on record since Oct. 17, 2017. Other recent recalls of similar products include Hitachi Proton Beam Therapy System Recall: 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 the Proteus 235 model name on the device or its packaging. The system may be sold under brand names Proteus Plus or Proteus ONE. This recall applies to medical devices used in proton therapy treatments.
Brand
Ion Beam Applications
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Verify Device Model
Check the device label for the model name, which may be Proteus 235, Proteus Plus, or Proteus ONE.
Where it went and when
Where it was distributed
Distributed in 6 states.
Listed by the agency
Not listed
FDA distribution: “US Distribution to the states of : MA, FL, VA, PA, OK, TN” States read from FDA’s own wording; “not listed” means the notice does not name it.
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-0934-2018 (December 5, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0934-2018 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.