Recall Z-2109-2018 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Ion Beam Applications S.A.
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.
| Date | Oct 28, 2016 |
| Status | Terminated |
| Reason | IBA is initiating this recall to address an issue identified with AdaPTinsight software and to reduce risk related to this problem. |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132847 | I2C Ion Beam Applications S.A., Nov 20, 2013 |