Class 2 Device Recall ProteusPLUS

• Date Initiated by Firm: March 09, 2017
• Date Posted: March 23, 2017
• Recall Status: Terminated on March 26, 2019
• Recall Number: Z-1695-2017
• Recall Event ID: 76696
• 510(K)Number: K101508
• Product Classification: System, radiation therapy, charged-particle, medical - Product Code LHN
• Product: Proteus 235
• Code Information: Serial numbers: PAT.000, PAT.001, PAT.003, PAT.006, PAT.108, PAT.111, SAT.119, SAT.120
• Recalling Firm/ Manufacturer: Ion Beam Applications S.A.; Chemin du Cyclotron, 3; Louvain La Neuve Belgium
• Manufacturer Reason for Recall: The Proton Therapy System can allow gantry rotation even if the snout is not properly locked.
• FDA Determined Cause: Component design/selection
• Action: A Field Safety Notice was mailed or handed to affected customers to inform them of the issue. The notice provides information on the issue, the risk for the patient and user and actions to be taken before starting gantry rotation. Corrective action developed by IBA are detailed.
• Quantity in Commerce: 8 worldwide, 4 in U.S.
• Distribution: Distributed in MA, FL, VA, and TN. China, South Korea, France and 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 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 and Original Applicant = ION BEAM APPLICATIONS S.A.