Class 2 Device Recall IBA

• Date Initiated by Firm: May 26, 2021
• Create Date: July 28, 2021
• Recall Status: Open, Classified
• Recall Number: Z-2155-2021
• Recall Event ID: 88196
• 510(K)Number: K101508
• Product Classification: System, radiation therapy, charged-particle, medical - Product Code LHN
• Product: Proteus 235-Proton Therapy System
• Code Information: Serial Numbers: PAT.107 (EU), PAT.108 (US), PAT.109 (US), PAT.115 (EU), SAT.117 (EU), SAT.118 (RU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.125 (IN), SAT.126 (US), SAT.132 (EU), SAT.133 (US).
• Recalling Firm/ Manufacturer: Ion Beam Applications S.A.; Chemin Du Cyclotron 3; Louvain-la-neuve Belgium
• Manufacturer Reason for Recall: if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated as prescribed, the treatment field may be delivered with an error in position
• FDA Determined Cause: Labeling design
• Action: IBA issued Urgent Medical Device Correction notification starting on May 27, 2021. Letter states reason for recall, health risk and action to take: IBA would like to remind Proteus235 users of the following warning present in the Clinical User Guide: As a Radiation Therapy Technologist (RTT), check before allowing the irradiation that the position of the selector switch of the external beam triggering interface is consistent with the prescription data in the patient file. There is a risk of mistreatment as the system does not automatically detect the gating prescription thereby always generating a continuous irradiation. Labelling change and training IBA will: - update the user manuals to recommend the customers to define a procedure for patients with gating prescribed in order to ensure that the system will be set correctly, - provide user training sessions about the preparation of a treatment with UBTI synchronization. The actions will be performed for your site by December 31, 2021. Your IBA representative is able to provide you with additional information and/or guidelines if necessary.
• Quantity in Commerce: 5 US; 8 OUS
• Distribution: FL, PA, TN, TX, VA Foreign: Germany, Italy, Russia, Sweden , India, Netherlands
• 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