UnratedMedical device recall · FDA · Published July 17, 2020
Proteus 235 Proton Therapy System Recall: Treatment Plan Loading Issue
Ion Beam Applications S.A. recalls Proteus 235 proton therapy systems due to inability to load treatment plans after abortion. Affected units have specific serial numbers from May 2019 (US) and October 2019 (EU).
Ion Beam Applications S.A. is recalling their Proteus 235 proton therapy systems because they can't properly load treatment plans after an abortion. This could lead to incomplete radiation treatments for patients. The recall affects specific units with serial numbers from May 2019 (US) and October 2019 (EU). Read more at govinfonow.com/recall/64690-proteus-235-proton-therapy-system-recall-treatment-plan-loading-issue.
“Proteus 235 Proton Therapy System Recall: Treatment Plan Loading Issue.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64690-proteus-235-proton-therapy-system-recall-treatment-plan-loading-issue. Based on FDA recall #Z-2715-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2715-2020%22&limit=1).
Ion Beam Applications S.A. recalled Proteus 235 proton therapy systems on July 17, 2020, because aborted irradiations cannot resume when treatment plans fail to load, the FDA said. The voluntary Class II recall affects two units distributed in Virginia and Belgium.
How to tell if you have it
Proteus 235 (brand names: Proteus Plus and Proteus ONE)
Serial Number: Manufacture date SAT.140 (US): manufactured May 2019
Serial Number: SBF.112 (EU): manufactured October 2019
The hazard
The firm identified an issue where the plan to complete treatment cannot be loaded, preventing the resumption of aborted irradiations.
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 Elekta MOSAIQ Oncology System Recall (Dec. 10, 2025) and Hitachi Proton Beam Therapy System Recall (Feb. 6, 2026).
How to tell if you have this one
Check for serial numbers starting with SAT.140 (US) manufactured in May 2019 or SBF.112 (EU) manufactured in October 2019. The product is a medical device used for proton therapy treatments.
Brand
Ion Beam Applications S.A.
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Serial Number
Look for serial numbers starting with SAT.140 (US) manufactured in May 2019 or SBF.112 (EU) manufactured in October 2019.
Where it went and when
Where it was distributed
Distributed in Virginia, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “US: VA OUS: Belgium” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Virginia.
Recall timeline
FDA terminated this recall 13 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 Proteus 235 is a medical device designed to produce and deliver proton beams for treating patients with localized tumors and other radiation-sensitive conditions.
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-2715-2020 (July 17, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2715-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.