Stop using now Medical device recall · FDA · Published September 18, 2023

IBA Proton Therapy System PROTEUS 235: Patient positioning risk of crushing

IBA recalls PROTEUS 235 proton therapy systems with specific versions due to risk of patient crushing during positioning. Affected units have unique serial numbers and software versions.

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

🇺🇸 FDA recall #Z-0295-2024Medical device Ion Beam Applications ›

Stop using this now

The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.

Take action

Contact the company

Recalling firmIon Beam Applications S.A.Chemin Du Cyclotron 3 · Ottignies-Louvain-La-Neuve, Belgium

✎ GovInfoNow plain-language explainer

IBA is recalling specific versions of their PROTEUS 235 proton therapy systems because the patient positioning system might move unexpectedly, potentially crushing the patient. This is serious but only affects medical devices used in hospitals. Read more at govinfonow.com/recall/57311-iba-proton-therapy-system-proteus-235-patient-positioning-risk-of.

Source Summary by GovInfoNow · govinfonow.com/recall/57311-iba-proton-therapy-system-proteus-235-patient-positioning-risk-of · Updated August 10, 2026 · FDA enforcement record: FDA #Z-0295-2024

Cite this page

“IBA Proton Therapy System PROTEUS 235: Patient positioning risk of crushing.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/57311-iba-proton-therapy-system-proteus-235-patient-positioning-risk-of. Based on FDA recall #Z-0295-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0295-2024%22&limit=1).

The FDA announced on Sept. 18, 2023, that Ion Beam Applications S.A. is recalling IBA Proton Therapy System - PROTEUS 235 units due to a potential patient crushing hazard. The agency classified the recall as Class II.

How to tell if you have it

IBA Proton Therapy System - PROTEUS 235
PTS-11 versions
PTS-12 versions with Orion PPS version OSS6.0
UPC: 05404013801138
Serial numbers (US): SAT133, SAT140, SBF113, SBF128, SBF135
Serial numbers (OUS): SAT125, SAT127, SAT132, SAT136, SBF107, SBF112, SBF117, SBF124, SBF125

The hazard

According to the FDA, the patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.

Context

GovInfoNow's records show Ion Beam Applications S.A. has 21 other recalls on record since Oct. 17, 2017. Other recent recalls include an IBA Proton Therapy System PROTEUS 235 recall dated Feb. 3, 2026, and an Ion Beam Applications PROTEUS 235 Proton Therapy System recall dated July 10, 2024. Hitachi issued a recall for its Proton Beam Therapy Systems on Feb. 6, 2026, citing positioning software anomaly risk.

How to tell if you have this one

Check if your system has serial numbers like SAT133, SAT140, SBF113, SBF128, SBF135 (US) or SAT125, SAT127, SAT132, SAT136, SBF107, SBF112, SBF117, SBF124, SBF125 (OUS). Also look for Orion PPS version OSS6.0 software.

Brand
Ion Beam Applications
Product
IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Stop using it now
Immediately cease operation of the affected PROTEUS 235 systems until a replacement is installed.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 4 states.

FDA distribution: “Worldwide - US Nationwide distribution in the states of Arkansas, Florida, Kansas, and Virginia and the countries of Belgium, France, India, Italy, Netherlands, Spain, Singapore, and Taiwan.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arkansas, Florida, Kansas, Virginia.

Recall timeline

FDA published this recall 2 months after the firm started it.

Sep 18, 2023Firm started the recall
Nov 14, 2023FDA classified it Class II
Nov 22, 2023Published in FDA’s Enforcement Report

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

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Link to this recall

<a href="https://govinfonow.com/recall/57311-iba-proton-therapy-system-proteus-235-patient-positioning-risk-of">IBA Proton Therapy System PROTEUS 235: Patient positioning risk of crushing (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-0295-2024 (September 18, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0295-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.