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U.S. Department of Health and Human Services

Class 2 Device Recall AdaPTinsight

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  Class 2 Device Recall AdaPTinsight see related information
Date Initiated by Firm October 28, 2016
Create Date June 07, 2018
Recall Status1 Terminated 3 on August 09, 2019
Recall Number Z-2109-2018
Recall Event ID 80219
510(K)Number K132847  
Product Classification System, radiation therapy, charged-particle, medical - Product Code LHN
Product 12C (AdaPTinsight)
Affected component: AdaPTinsight software

Product Usage:
12C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy system.
Code Information Affected units: SAT.123, SAT.126, PAT.115, SAT.122 and SBF.101
Recalling Firm/
Manufacturer		 Ion Beam Applications S.A.
Chemin du Cyclotron, 3
Louvain La Neuve Belgium
Manufacturer Reason
for Recall		 IBA is initiating this recall to address an issue identified with AdaPTinsight software and to reduce risk related to this problem.
FDA Determined
Cause 2		 Software change control
Action IBA mailed an Urgent Field Safety Notice to affected customers on 10/28/2016 to inform them of the issue. The issue will be solved in AdaPTinsights versions starting from Al 2.0. The solution was to be deployed on impacted IBA Proton Therapy sites by September 2017.
Quantity in Commerce 5 units (12C)
Distribution Worldwide Distribution - US Nationwide in the states of LA, TX, Italy, Sweden and France. Each country's National Competent Authorities were notified of the firm's Field Safety Notice.
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.
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