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.
FDA Recall Z-2109-2018 · Posted None
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Recalling FirmIon Beam Applications S.A.
Recall StatusTerminated
Product CodeLHN
Date Initiated2016-10-28
Date Terminated2019-08-09
Product Quantity5 units (12C)
Reason for Recall
IBA is initiating this recall to address an issue identified with AdaPTinsight software and to reduce risk related to this problem.
Firm 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.
Root Cause
Software change control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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