Use caution Medical device recall · FDA · Published February 15, 2022

Proton Therapy Systems: Risk of Incorrect Beam Range During Treatment Pauses

Ion Beam Applications recalls ProteusPLUS and ProteusONE proton therapy systems due to potential risk of incorrect beam range after resuming treatment pauses. This could lead to unintended radiation delivery to patients.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0747-2022Medical device Ion Beam Applications ›

Use caution until it’s fixed

When resuming from a beam pause, the Proton Therapy System does not verify whether the beam range has not been manually modified during the pause and is still the prescribed one. Therefore, if an operator manually modified the range during a pause, there is a risk that a portion of the treatment beam after the resume is delivered with an error in range

Take action

Contact the company

Recalling firmIon Beam Applications S.A.Chemin Du Cyclotron 3 · Louvain-la-neuve, Belgium

✎ GovInfoNow plain-language explainer

Ion Beam Applications is recalling two proton therapy systems (ProteusPLUS and ProteusONE) because they may deliver incorrect radiation doses to patients after resuming treatment sessions. This risk occurs if the operator manually changes the beam range during a treatment pause, which could cause unintended radiation exposure. Read more at govinfonow.com/recall/61141-proton-therapy-systems-risk-of-incorrect-beam-range-during-treatment.

Source Summary by GovInfoNow · govinfonow.com/recall/61141-proton-therapy-systems-risk-of-incorrect-beam-range-during-treatment · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0747-2022

Cite this page

“Proton Therapy Systems: Risk of Incorrect Beam Range During Treatment Pauses.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61141-proton-therapy-systems-risk-of-incorrect-beam-range-during-treatment. Based on FDA recall #Z-0747-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0747-2022%22&limit=1).

The FDA announced on Feb. 15, 2022, that Ion Beam Applications S.A. is recalling ProteusPLUS and ProteusONE- proton therapy systems due to a risk of treatment beam range errors. The agency said the devices fail to verify if the beam range was manually modified during a pause.

How to tell if you have it

Ion Beam Applications ProteusPLUS and ProteusONE-
UPC 05404013801138
UDI (01)05404013801138
Proteus 235; PAT.003 (KR), PAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT109 (US), PAT.110 (US), PAT.111 (EU), PAT.112 (US), PAT.113 (US), PAT.114 (EU), PAT.115 (EU), SAT.116 (US), SAT.117 (EU), SAT.118 (RU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.123 (US), SAT.125 (IN), SAT.126 (US), SAT.127 (TW), SAT.132 (EU), SAT.133 (US), SAT.136 (IN), SAT.140 (US), SBF.101 (EU), SBF.103 (JP), SBF.104 (JP), SBF.105 (US), SBF.107 (FR), SBF.109 (UK), SBF.110 (UK), SBF.112 (EU), SBF.113 (US), SBF.115 (UK), SBF.117 (EU), SBF.128 (US)

The hazard

According to the FDA, when resuming from a beam pause, the Proton Therapy System does not verify whether the beam range has been manually modified during that pause. Consequently, if an operator manually modified the range, there is a risk that a portion of the treatment beam after the resume is delivered with an error in range.

Context

GovInfoNow's records show Ion Beam Applications S.A. has 21 other recalls on record since Oct. 17, 2017. Recent brand recalls include a Feb. 3, 2026, recall for the IBA Proton Therapy System PROTEUS 235 regarding disabled safety interfaces and a July 10, 2024, recall for collision detection issues in the same system. Other recent recalls of similar products include Hitachi Proton Beam Therapy Systems positioning software anomaly risks (Feb. 6, 2026) and RayStation/RayPlan Software 11A radiation dose calculation risks (Nov. 28, 2025).

How to tell if you have this one

The recalled products are named ProteusPLUS and ProteusONE. They are used for proton beam therapy in medical treatments. The specific model numbers and serial numbers are not clearly stated in the recall notice.

Brand
Ion Beam Applications
Product
ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check System Status
Verify if the system has been used for proton beam therapy treatments.
Contact Manufacturer
Reach out to Ion Beam Applications for guidance on system safety and potential remedies.

Where it went and when

Where it was distributed

Distributed in 12 states, and outside the U.S.

FDA distribution: “IL, KS, LA, FL, MI, OK, PA, NJ, TN, TX, VA, WA Foreign: Belgium, England, Germany, France, Czech Republic, Italy, Poland, Russia, Spain, Sweden, South Korea, Taiwan, Netherlands,” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Florida, Illinois, Kansas, Louisiana, Michigan, New Jersey, Oklahoma, Pennsylvania, Tennessee, Texas, Virginia, Washington.

Recall timeline

FDA published this recall 29 days after the firm started it.

Feb 15, 2022Firm started the recall
Mar 10, 2022FDA classified it Class II
Mar 16, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More Ion Beam Applications recalls

Link to this recall

<a href="https://govinfonow.com/recall/61141-proton-therapy-systems-risk-of-incorrect-beam-range-during-treatment">Proton Therapy Systems: Risk of Incorrect Beam Range During Treatment Pauses (GovInfoNow)</a>

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-0747-2022 (February 15, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0747-2022 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.