Class 2 Device Recall IBA Proton Therapy System PROTEUS 235

• Date Initiated by Firm: July 10, 2024
• Date Posted: August 21, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2693-2024
• Recall Event ID: 95024
• 510(K)Number: K163500
• Product Classification: System, radiation therapy, charged-particle, medical - Product Code LHN
• 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
• Code Information: 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).
• FEI Number: 3000256071
• Recalling Firm/ Manufacturer: Ion Beam Applications S.A.; Chemin Du Cyclotron 3; Ottignies-Louvain-La-Neuve Belgium
• For Additional Information Contact: same; 104758811
• Manufacturer Reason for Recall: Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues
• FDA Determined Cause: Process design
• Action: 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
• Quantity in Commerce: 19 units
• Distribution: IL,LA, NJ, MI,OK, TN, TX, VA, WA Foreign: Czech Republic France Germany Italy Japan Poland Russia Sweden
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LHN