Class 2 Device Recall IBA

• Date Initiated by Firm: April 20, 2022
• Date Posted: May 27, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1205-2022
• Recall Event ID: 90213
• 510(K)Number: K163500
• Product Classification: System, radiation therapy, charged-particle, medical - Product Code LHN
• Product: Proteus235- Proton Therapy System: 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: PAT108 (US), PAT112 (US), SAT116 (US). PAT107 (EU).
• Recalling Firm/ Manufacturer: Ion Beam Applications S.A.; 3 Chemin Du Cyclotron; Louvain-la-neuve Belgium
• Manufacturer Reason for Recall: First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the irradiated area may receive more dose than prescribed
• FDA Determined Cause: Under Investigation by firm
• Action: ***UPDATE 12/22/22*** Ion Beam Application S.A. (IBA S.A.) issued an Amended Urgent Medical Device Correction to customers starting December 22, 2022 (supersedes previous letter Sept 15, 2022). Letter provides quantitative data about the impact on the dose distribution, and the description of the solution (software upgrade) as well as the time schedule for its deployment. Cyclic check thresholds verification and software upgrade Additionally, IBA will provide each impacted customer with a report including: - The list of the Uniform Scanning fields with the first layer entirely delivered with the tuning setpoints and a significant difference (above 0.3V) between the prescribed setpoints and the tuning setpoints, - The modelled maximum and average dose errors for these fields IBA will upgrade the PTS version to ensure that: - the irradiation of a layer cannot be started if the Scanning Magnet setpoints for the layer are not properly sent to the Scanning Magnet Power Supply, and - no setpoints request can be lost (even if previous requests are not yet executed or completed). The report including the identified impacted Uniform Scanning fields with the modelled maximum and average dose errors for these fields will be provided to each impacted customer by February 28, 2023. On the sites where IBA has not yet finalized the verification and the possible adaptation of the field size and dose rate cyclic check thresholds, this action will be completed by January 15, 2023. The PTS version upgrade will be deployed on your site by March 31, 2023. Contact: HEAD OF POST MARKET VIGILANCE Sonia PINEL Vigilance@iba-group.com +32 10 497 516 ___________________________________________________________________________ **UPDATED 9/15/22*** The cause of these events has been identified as a software race condition between the different tasks that handle the Scanning Magnet Electronic Unit (SMEU). IBA CAPA PNC-543 has been opened. The root cause analysis is in progress. This recall re
• Quantity in Commerce: 4 units
• Distribution: Worldwide distribution - US Nationwide distribution in the states of IL, VA, WA and the country of Germany.
• 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