Z-1497-2026Class II

IBA Proton Therapy System - PROTEUS 235

Name: Z-1497-2026 IBA Proton Therapy System - PROTEUS 235
Creator: Ion Beam Applications S.A.
Published: 2026-02-03
License: https://open.fda.gov/license/

Ion Beam Applications S.A. / initiated 2026-02-03 / Open, Classified / root cause: software

FDA source

Ion Beam Applications S.A. began a recall of IBA Proton Therapy System - PROTEUS 235 on 2026-02-03. FDA classified it as Class II and gives the reason as "It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration. In this condition, the TSS does not interrupt the beam delivery if the Healthy Signal...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1497-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-03
Posted: 2026-03-06
Recalling firm: Ion Beam Applications S.A.
Product: IBA Proton Therapy System - PROTEUS 235
Product code: LHN System, Radiation Therapy, Charged-Particle, Medical
Reason for recall: It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration. In this condition, the TSS does not interrupt the beam delivery if the Healthy Signal from an external gating device is lost. This may lead to a risk of mistreatment when external gating devices are used.
Root cause tag: software
FDA root cause: Software design
Action: On February 3, 2026 Urgent Medical Device Correction letters were sent to customers. Letter provides awareness of the Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration. On-site modification of the devices will be performed by IBA with a TSS Configuration update. The update will be deployed at the impacted sites by June 2026.
Quantity in commerce: 4 units (1 US, 3 OUS)
Distribution: Worldwide - US Nationwide distribution in the state of FL and the countries of Italy and Japan.
Product codes and lots: PROTEUS 235; UDI-DI: 05404013801138; Serial Numbers: SBF103 (JP), SBF124 (EU), SBF133 (US), SBF140 (EU)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1497-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1497-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-18	2026-03-06

Product code LHN

K163500Class IIIBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)Ion Beam Applications S.A. / cleared 2017-08-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)