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U.S. Department of Health and Human Services

Class 2 Device Recall ProteusPLUS

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  Class 2 Device Recall ProteusPLUS see related information
Date Initiated by Firm March 09, 2017
Date Posted March 23, 2017
Recall Status1 Terminated 3 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/
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 2
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.