Class 2 Device Recall Proteus 235

• Date Initiated by Firm: October 17, 2017
• Create Date: March 08, 2018
• Recall Status: Terminated on March 29, 2019
• Recall Number: Z-0930-2018
• Recall Event ID: 79227
• 510(K)Number: K101508
• Product Classification: System, radiation therapy, charged-particle, medical - Product Code LHN
• Product: Proteus 235, graphite block 8
• Code Information: PAT.115, SAT.116
• Recalling Firm/ Manufacturer: Ion Beam Applications S.A.; Chemin du Cyclotron, 3; Louvain La Neuve Belgium
• Manufacturer Reason for Recall: IBA identified incorrect screw holes depth in graphite block 8 with respect to the degrader
• FDA Determined Cause: Component design/selection
• Action: On July 17, 2017 An Urgent Field Safety Notice was issued to customers with the following user action: In case a patient treatment plan requires the use of the block 8, it is recommended to perform a full range verification during the patient treatment plan QA check. After the replacement of the graphite block 8, it is recommended to verify there is no effect on the Bragg peak.
• Quantity in Commerce: 3
• Distribution: WA
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

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