Ion Beam Applications S.A. recalls Proteus 235 proton beam devices with specific versions and serial numbers due to risk of incorrect patient positioning during radiation treatment. Affected units may require correction to prevent treatment errors.
Correction vector confirmation message is lost if access point is changed after sending the correction vector. As a result, the patient will be treated in the setup position or treatment position instead of the corrected position.
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Contact the company
📍Recalling firmIon Beam Applications S.A.Chemin du Cyclotron, 3 · Louvain La Neuve, Belgium
✎ GovInfoNow plain-language explainer
Ion Beam Applications S.A. recalls specific versions of their Proteus 235 proton beam treatment devices. The recall is due to a risk that correction vectors may be lost if the access point changes after sending the correction, potentially leading to incorrect patient positioning during radiation treatment. Read more at govinfonow.com/recall/71060-proteus-235-proton-beam-device-recall-correction-vector-errors-risk.
“Proteus 235 Proton Beam Device Recall: Correction Vector Errors Risk Incorrect Patient.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71060-proteus-235-proton-beam-device-recall-correction-vector-errors-risk. Based on FDA recall #Z-2424-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2424-2018%22&limit=1).
The FDA announced on May 16, 2018, that Ion Beam Applications S.A. recalled three Proteus 235 proton therapy devices due to a hazard where correction vector confirmation messages could be lost. This defect risks treating patients in the wrong position.
How to tell if you have it
Ion Beam Applications S.A. Proteus 235
Version PTS-11.0.1.2 and PTS-11.0.2
Serial Numbers: SAT.122 (EU), SAT.132 (EU), SAT.133 (US)
The hazard
The recall record states that the correction vector confirmation message is lost if the access point is changed after sending the correction vector. As a result, the patient will be treated in the setup position or treatment position instead of the corrected position.
Context
GovInfoNow's records show Ion Beam Applications S.A. has 21 other recalls on record since October 17, 2017. Other recent recalls of similar products include Hitachi Proton Beam Therapy System Recall: Positioning Software Anomaly Risk (February 6, 2026) and Elekta Leksell GammaPlan 11.1 Software Recall: Risk of Incorrect Patient Irradiation (December 12, 2025).
How to tell if you have this one
Check for the Proteus 235 device with version numbers PTS-11.0.1.2 or PTS-11.0.2. Affected units have serial numbers SAT.122 (EU), SAT.132 (EU), or SAT.133 (US).
Brand
Ion Beam Applications S.A.
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Version
Verify the device version number on the Proteus 235 to see if it matches PTS-11.0.1.2 or PTS-11.0.2.
Review Serial Number
Check the serial number on the device; affected units have SAT.122 (EU), SAT.132 (EU), or SAT.133 (US).
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide Distribution - US Nationwide in the states of FL and the countries of Sweden, The Netherlands” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 5 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-2424-2018 (May 16, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2424-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 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.