Z-1945-2024Class II

IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of...

Name: Z-1945-2024 IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of...
Creator: Ion Beam Applications S.A.
Published: 2024-05-10
License: https://open.fda.gov/license/

Ion Beam Applications S.A. / initiated 2024-05-10 / Open, Classified / root cause: design

FDA source

Ion Beam Applications S.A. began a recall of IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other... on 2024-05-10. FDA classified it as Class II and gives the reason as "Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1945-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-10
Posted: 2024-06-03
Recalling firm: Ion Beam Applications S.A.
Product: IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Product code: LHN System, Radiation Therapy, Charged-Particle, Medical
Reason for recall: Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances
Root cause tag: design
FDA root cause: Device Design
Action: Iba issued Urgent Medical Device Correction Letter on May 10, 2024 via IBA responsible directly to customer site either by hand or by email. Letter states reason for recall, health risk and action to take: ACTION BEING TAKEN BY IBA Monitoring of the deflector, software upgrade. 7.2 CORRECTIVE ACTIONS Software upgrade 7.3 PREVENTIVE ACTIONS Waiting for the solution to be deployed, IBA will distribute an Internal User Notice to IBA operators of impacted sites with instructions to monitor the deflector and stop the irradiation when necessary. 7.4 TIME SCHEDULE FOR THE IMPLEMENTATION OF THE DIFFERENT ACTIONS The Internal User Notice will be provided to IBA operators by May 10, 2024. The corrective action will be implemented at your site by June 2025. Contact: Sonia PINEL [email protected]
Quantity in commerce: 2 units
Distribution: Worldwide - US Nationwide distribution in the state of Virginia and the country of India.
Product codes and lots: UDI: SAT140: (01)05404013814015(11)190507(21)SAT140 SAT136: (01)05404013801138(11)201105(21)SAT136 Serial Numbers: SAT136, SAT140 PTS-11 versions from PTS-11.1 and PTS-12 versions, with C230 accelerator

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1945-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1945-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-12	2024-06-03

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)