Proteus 235 recallZ-1945-2024 · Ion Beam Applications S.A. · initiated May 10, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ion Beam Applications S.A. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances
FDA root cause category: Device Design
What the company is doing
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]
Recall details
- Recall number
- Z-1945-2024
- Status
- Open, Classified
- Initiated by the company
- May 10, 2024
- Posted by the FDA
- Jun 3, 2024
- Recalling firm
- Ion Beam Applications S.A.
- Quantity
- 2 units
- Product code
- LHN
- FDA submissions
- K163500
- Distribution
- Worldwide - US Nationwide distribution in the state of Virginia and the country of India.
Product description
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.
Code information (models, lots, serial numbers)
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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- IBA Proton Therapy System – Proteus 235 Proteus PLUS/Proteus ONEIon Beam Applications SA · System, Radiation Therapy, Charged-Particle, Medical8 recalls1 report
- Proteus 235 Proteus PLUSIon Beam Applications SA · System, Radiation Therapy, Charged-Particle, Medical1 recall1 report
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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