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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = LHN
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