IBA Proton Therapy System - PROTEUS 235. PTS-11 versions… recallZ-0295-2024 · Ion Beam Applications S.A. · initiated Sep 18, 2023
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
The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.
FDA root cause category: Device Design
What the company is doing
An Urgent Medical Device Correction issued on October 4, 2023 by email or in-person visit. Waiting for the solution to be deployed, IBA requires the user to only request jog translation motions to recover from a collision situation. IBA also recommends the user to post the notice near the device to remind them of this requirement until the software correction can be deployed. IBA provide an updated Urgent Medical Device Correction notification by November 30, 2023 with a target date for deployment of the software solution to your site. Customers are to complete and return the acknowledgement form to IBA. IBA Contact: Sonia Pinel Head of Post Market Vigilance, Email: [email protected], Helpdesk: +32 2 507 20 81 (available 24/7).
Recall details
- Recall number
- Z-0295-2024
- Status
- Open, Classified
- Initiated by the company
- Sep 18, 2023
- Posted by the FDA
- Nov 14, 2023
- Recalling firm
- Ion Beam Applications S.A.
- Quantity
- 5 (US), 9 (OUS)
- Product code
- LHN
- FDA submissions
- K163500
- Distribution
- Worldwide - US Nationwide distribution in the states of Arkansas, Florida, Kansas, and Virginia and the countries of Belgium, France, India, Italy, Netherlands, Spain, Singapore, and Taiwan.
Product description
IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System.
Code information (models, lots, serial numbers)
UDI-DI: (01)05404013801138. Serial numbers (US): SAT133, SAT140, SBF113, SBF128, SBF135 & (OUS): SAT125, SAT127, SAT132, SAT136, SBF107, SBF112, SBF117, SBF124, & SBF125.
Devices named in this recall
1 device 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
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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