Proteus 235 Proton Therapy System Recall: Risk of Patient Misalignment During Treatment
Ion Beam Applications recalls Proteus 235 proton therapy systems due to potential patient misalignment during multi-isocenter treatments. This medical device is used for cancer treatment. Affected units may require correction to ensure safe radiation delivery.
Use caution until it’s fixed
There is a risk of misalignment of the patient when using treatment plans with multiple isocenters.
Contact the company
What happened, in plain English
Ion Beam Applications is recalling its Proteus 235 proton therapy system because it can misalign patients during treatments involving multiple radiation targets. This could lead to improper radiation delivery and potential treatment complications. Read more at govinfonow.com/recall/72532-proteus-235-proton-therapy-system-recall-risk-of-patient-misalignment.
Source Summary by GovInfoNow · govinfonow.com/recall/72532-proteus-235-proton-therapy-system-recall-risk-of-patient-misalignment · Updated September 14, 2026 · FDA enforcement record: FDA #Z-0938-2018
Cite this page
“Proteus 235 Proton Therapy System Recall: Risk of Patient Misalignment During Treatment.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/72532-proteus-235-proton-therapy-system-recall-risk-of-patient-misalignment. Based on FDA recall #Z-0938-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0938-2018%22&limit=1).
Why it’s dangerous
The system can misalign patients when using treatment plans with multiple isocenters. This misalignment might cause radiation to be delivered to unintended areas, potentially affecting treatment effectiveness or safety.
Who’s affected
Patients receiving proton therapy using the Proteus 235 system are most at risk. Healthcare providers using this device for cancer treatment may also be affected.
How to tell if you have this one
The Proteus 235 is a proton therapy system used for cancer treatment. It was sold with specific patent numbers listed in the recall notice.
- Brand
Ion Beam Applications- Category
Medical device
What to do — step by step
Check for Misalignment
Verify if your treatment plan uses multiple isocenters, as this may cause patient misalignment.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationally” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3.6 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-0938-2018 (November 17, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0938-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 14, 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.