IBA Proton Therapy System - PROTEUS 235- Designed to… recallZ-2693-2024 · Ion Beam Applications S.A. · initiated Jul 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

Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues

FDA root cause category: Process design

What the company is doing

IBA isued Urgent Medical Device Correction letter on July 10, 2024. Letter states reason for recall, health risk and action to take: IBA would like to remind you as IBA Proton Therapy System -PROTEUS 235 user of the warnings present in your Clinical User's Guide which emphasize the importance of carefully monitoring the patients behavior during the different treatment phases. IBA would like to also remind you that the manual hand crank could be used by the system operator for the emergency release of the Patient Positioning System in the situations listed in the Clinical User's Guide and Accelerator Operator's Guide and by following the instructions described in both guides. To be signed and given back to IBA representative on site. PTS-8, PTS-10 and PTS-11 versions: Software upgrade IBA will update the software of the Positioning Management System in order that, after a collision, the request to temporarily disable the collision detection will be sent until the status of the collision detection is well disabled. This solution will be deployed at your site by March 2026. PTS-12 versions: users training and labeling change IBA will provide customer training on the system behavior in PTS-12 versions following collision detections. Additionally, IBA will update the labeling to clarify that users can also move the snout or gantry to go out collision situations. These solutions will be deployed at your site by January 2025

Recall details

Recall number: Z-2693-2024
Status: Open, Classified
Initiated by the company: Jul 10, 2024
Posted by the FDA: Aug 21, 2024
Recalling firm: Ion Beam Applications S.A.
Quantity: 19 units
Product code: LHN
FDA submissions: K163500
Distribution: IL,LA, NJ, MI,OK, TN, TX, VA, WA Foreign: Czech Republic France Germany Italy Japan Poland Russia Sweden

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-DI: (01)05404013801138 Serial Numbers; PAT.108 (US), PAT.110 (US), PAT.111 (FR), PAT.112 (US), PAT.113 (US), PAT.114 (CZ), PAT.115 (IT), SAT.116 (US), SAT.117 (PL), SAT.118 (RU), SAT.119 (US), SAT.120 (DE), SAT.122 (SE), SAT.123 (US), SAT.126 (US), SBF.101 (FR), SBF.103 (JP), SBF.104 (JP), SBF.105(US).

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 ONE
Ion Beam Applications SA · System, Radiation Therapy, Charged-Particle, Medical
8 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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