Use cautionMedical device recall · FDA · Published May 10, 2024
Ion Beam Applications PROTEUS 235 Proton Therapy System Recall: Irradiation Risk
Ion Beam Applications recalls PROTEUS 23:5 proton therapy systems with C230 accelerator control units that may cause irradiation if critical parameters are outside tolerances. Affected units have specific serial numbers and versions.
“Ion Beam Applications PROTEUS 235 Proton Therapy System Recall: Irradiation Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55133-ion-beam-applications-proteus-235-proton-therapy-system-recall-irradiation. Based on FDA recall #Z-1945-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1945-2024%22&limit=1).
The FDA announced on May 10, 2024, that Ion Beam Applications S.A. is recalling its IBA Proton Therapy System - PROTEUS 235 because irradiation may not be interrupted when critical accelerator parameters are out of tolerance. The agency classified the recall as Class II.
How to tell if you have it
IBA Proton Therapy System - PROTEUS 235
UPC 05404013801138
UPC 05404013814015
Serial numbers SAT136 and SAT140 PTS-11 versions from PTS-11.1 and PTS-12, with C230 accelerator
The hazard
According to the FDA, irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances.
Context
GovInfoNow's records show Ion Beam Applications S.A. has had 21 other recalls on record since October 17, 2017. Other recent recalls of similar products include IBA Proton Therapy System PROTEUS 235 Recall (February 3, 2026), Ion Beam Applications PROTEUS 235 Proton Therapy System Recall (July 10, 2024), and Ion Beam Applications Recalls Proton Therapy Systems Due to Safety Mechanism Deactivation (July 8, 2024). Other recent recalls of similar products include Hitachi Proton Beam Therapy Systems: Positioning Software Anomaly Risk (February 6, 2026), RayStation/RayPlan Software 11A Recalls: Radiation Dose Calculation Risk (November 28, 2025), and Hitachi Proton Beam Therapy System Recall: Positioning Software Anomaly Risk (February 6, 2026).
How to tell if you have this one
Check for serial numbers starting with SAT136 or SAT140, and versions from PTS-11.1 and PTS-12. The system was sold with specific UDI codes and dates.
Brand
Ion Beam Applications
Product
IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Your System
Identify if your PROTEUS 235 system has serial numbers starting with SAT136 or SAT140 and versions from PTS-11.1 or PTS-12.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide - US Nationwide distribution in the state of Virginia and the country of India.” 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 published this recall 33 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-1945-2024 (May 10, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1945-2024 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.