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.

Reason: IBA is initiating this recall to address an issue identified with AdaPTinsight software and to reduce risk related to this problem.

Code information: Affected units: SAT.123, SAT.126, PAT.115, SAT.122 and SBF.101

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.