UnratedMedical device recall · FDA · Published November 29, 2021
Ion Beam Proteus 235 Software Recall: Risk of Patient Treatment Errors
Ion Beam Applications recalls Proteus 235 software versions before PTS-8.7.2 due to potential patient treatment errors from software conflicts between clinical and test environments.
Proton Therapy System (PTS) software can be started in the clinical environment (clinical user) while some processes are still running in the test environment (tcs user). Initiating the startup of the clinical processes in the environment is not prevented even if some processes of the test environment (tcs) are still running. It may lead to situations where the system is using test processes without notifying the clinical user. If the versions of the processes are different between both environments, this could have an impact on patient treatments.
Ion Beam Applications is recalling Proteus 235 software versions older than PTS-8.7.2 because software conflicts between clinical and test environments could lead to patient treatment errors. This affects medical facilities using the system for proton therapy. Read more at govinfonow.com/recall/61495-ion-beam-proteus-235-software-recall-risk-of-patient-treatment.
“Ion Beam Proteus 235 Software Recall: Risk of Patient Treatment Errors.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61495-ion-beam-proteus-235-software-recall-risk-of-patient-treatment. Based on FDA recall #Z-0466-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0466-2022%22&limit=1).
The FDA announced on November 29, 2021, that Ion Beam Applications S.A. is recalling its Proteus 235 Proton Therapy Systems with PTS-8 versions prior to PTS-8.7.2 due to software hazards. The agency issued recall number Z-0466-2022 for the voluntary Class II action affecting five devices.
According to the FDA, the system's software can be started in the clinical environment while test environment processes are still running. This may lead to the system using test processes without notifying the clinical user. If process versions differ between environments, this could impact patient treatments.
Context
GovInfoNow's records show Ion Beam Applications S.A. has 21 other recalls on record since October 17, 2017. Recent brand recalls include a February 3, 2026, notice regarding disabled Universal Beam Triggering Interface and a July 10, 2024, recall for collision detection issues. Other recent recalls of similar products include the Hitachi Proton Beam Therapy System Recall (February 6, 2026) and the Elekta MOSAIQ Oncology System Software Recall (May 21, 2026).
How to tell if you have this one
Check if your Proteus 235 software version is older than PTS-8.7.2. The recall covers specific patent registrations in the US and EU.
Brand
Ion Beam Applications
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your Proteus 235 software version to see if it's older than PTS-8.7.2.
Where it went and when
Where it was distributed
Distributed in 5 states.
Listed by the agency
Not listed
FDA distribution: “IN USA: VA, OK, NJ, TN OUS: Czech Republic.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Indiana, New Jersey, Oklahoma, Tennessee, Virginia.
Recall timeline
FDA terminated this recall 2.2 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-0466-2022 (November 29, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0466-2022 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.