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U.S. Department of Health and Human Services

Class 2 Device Recall Proteus 235 and Proteus ONE proton therapy systems

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  Class 2 Device Recall Proteus 235 and Proteus ONE proton therapy systems see related information
Date Initiated by Firm May 18, 2016
Create Date July 03, 2017
Recall Status1 Terminated 3 on February 08, 2019
Recall Number Z-2672-2017
Recall Event ID 77620
510(K)Number K132919  
Product Classification System, radiation therapy, charged-particle, medical - Product Code LHN
Product Proteus 235 and Proteus ONE proton therapy systems
Code Information Code/Serial Numbers: PAT.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.110, PAT.111, PAT.112, PAT.113, PAT.114, PAT.115, SAT.116, SAT.117, SAT.119, SAT.120, SAT.122, SAT.123 and SAT.126
Recalling Firm/
Ion Beam Applications S.A.
Chemin du Cyclotron, 3
Louvain La Neuve Belgium
Manufacturer Reason
for Recall
Recall is being initiated to address on-site software installations not being performed consistently with IBA standard operating procedures.
FDA Determined
Cause 2
Employee error
Action An Urgent Field Safety Notice MID-54097 was mailed to affected customers to inform that IBA plans to deploy a new software by March 2017 to correct the issue. Customers were reminded to follow standard protocol until the software updates are deployed.
Quantity in Commerce 18 worldwide and 10, in the U.S.
Distribution Products distributed to FL, VA, PA, OK, IL, NJ, WA, TN, LA, TX, South Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden
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.