Ion Beam Applications recalls Proteus 235 proton therapy systems where user signatures longer than 10 characters prevent resuming aborted treatments. This medical device affects specific models manufactured between May and November 2019.
Signature from the user is necessary to proceed with specific actions in the Proton Therapy System (PTS). IBA became aware that the PTS does not accept user names with more than ten characters. It is an issue when the user has no other choice than resuming an aborted treatment field based on the overall delivered dose displayed on the Dose Counter Electronic Unit (DCEU). User s signature is required to perform this action. If the signature contains more than ten characters, the user will not be able to complete the aborted treatment field. An additional issue applies to Electronic Medical Record (EMR) centric sites and may increase the probability of not being able to complete an aborted treatment field. It is not possible, in a new session, to resume from a local partial archive if the Patient Positioning System (PPS) position has changed. If the user captures the PPS position at every session in the Oncology Information System (OIS) just after the setup process, the prescribed PPS position is changed for the next session in the OIS. This includes the partial continuation session. Therefore, when comparing the prescribed PPS position between OIS and local database, the PTS sees a difference and rejects the local partial archive. This problem forces the user to resume the interrupted irradiation based on the overall delivered dose displayed on the DCEU instead of resuming from the full details of the interrupted beam.
“Proteus 235 Proton Therapy System: Signature Length Issue Prevents Treatment Resumption.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65347-proteus-235-proton-therapy-system-signature-length-issue-prevents-treatment. Based on FDA recall #Z-2773-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2773-2020%22&limit=1).
The FDA announced on April 21, 2020, that Ion Beam Applications S.A. is recalling Proteus 235 proton therapy systems due to software issues preventing users from completing aborted treatments. The agency issued recall number Z-2773-2020 for the medical devices.
How to tell if you have it
Proteus 235 (brand names: Proteus Plus and Proteus ONE)
Serial Number: SAT.140 (US): manufactured May 2019
Serial Number: SBF.112 (EU): manufactured October 2019
Serial Number: SBF.113 (US): manufactured June 2019
Serial Number: SBF.117 (EU): manufactured November 2019
The hazard
The system does not accept user names with more than ten characters, which prevents users from resuming aborted treatment fields based on the Dose Counter Electronic Unit. Additionally, the system rejects local partial archives if the Patient Positioning System position has changed between sessions.
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 IBA Proton Therapy System PROTEUS 235 Recall: Risk of Mistreatment Without Safety Check (February 3, 2026), Ion Beam Applications PROTEUS 235 Proton Therapy System Recall: Collision Detection Issues (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 System Recall: Positioning Software Anomaly Risk (February 6, 2026), Hitachi Proton Beam Therapy Systems: Positioning Software Anomaly Risk (February 6, 2026), and Elekta MOSAIQ Oncology System Recall: Risk of Overtreatment in Particle Therapy (December 10, 2025).
How to tell if you have this one
Check for the Proteus 235 system with brand names Proteus Plus or Proteus ONE. These devices were manufactured between May 2019 (US) and November 2019 (EU) with serial numbers starting with SAT.140 or SBF.112 through SBF.117.
Brand
Ion Beam Applications
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Signature Length
Verify if your user signature exceeds 10 characters, which may prevent resuming interrupted treatments.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of FL, VA and the countries of Belgium, Spain.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Virginia.
Recall timeline
FDA terminated this recall 16 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-2773-2020 (April 21, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2773-2020 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.