Use cautionMedical device recall · FDA · Published June 14, 2021
Proteus 235 Proton Therapy System Recall: Misleading Disconnect Messages
Ion Beam Applications recalls Proteus 235 proton therapy systems due to misleading disconnect messages that may cause incorrect patient treatment. Affected units were sold with specific patents and software versions.
Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment
“Proteus 235 Proton Therapy System Recall: Misleading Disconnect Messages.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62338-proteus-235-proton-therapy-system-recall-misleading-disconnect-messages. Based on FDA recall #Z-2434-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2434-2021%22&limit=1).
The FDA announced on June 14, 2021, that Ion Beam Applications S.A. is recalling its Proteus 235- proton therapy systems because users may be misled by a popup message when the Oncology Information System appears disconnected, potentially causing patient mistreatment. The agency classified the recall as Class II and ongoing.
According to the FDA, users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected. This error may cause mistreatment of patients.
Context
GovInfoNow's records show Ion Beam Applications S.A. has had 21 other recalls on record since October 17, 2017. Other recent recalls of similar products include IBA Proton Therapy System PROTEUS 235 Recall (February 3, 2026), Ion Beam Applications PROTEUS 235 Proton Therapy System Recall (July 10, 2024), Ion Beam Applications Recalls Proton Therapy Systems Due to Safety Mechanism Deactivation (July 8, 2024), Hitachi Proton Beam Therapy System Recall (February 6, 2026), Elekta MOSAIQ Oncology System Software Recall (May 21, 2026), and Hitachi Proton Beam Therapy Systems: Positioning Software Anomaly Risk (February 6, 2026).
How to tell if you have this one
Check for the Proteus 235 proton therapy system with the specific software versions mentioned in the recall notice. The device is used for treating localized tumors and other radiation-sensitive conditions.
Brand
Ion Beam Applications
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check System Status
Verify if the system displays misleading disconnect messages that could cause incorrect patient treatments.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 10 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of FL, OK, VA, IL, NJ, TN, WA, LA, TX, MI and the countries of Germany, Italy, Russia, Sweden, India, Japan, France, England, Spain.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Illinois, Louisiana, Michigan, New Jersey, Oklahoma, Tennessee, Texas, Virginia, Washington.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-2434-2021 (June 14, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2434-2021 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.