medical Class II Updated 2018-06-13

Ion Beam Applications S.A. recalls 12C (AdaPTinsight) Affected component: AdaPTinsight softwar

Recalled 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.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Affected units: SAT.123, SAT.126, PAT.115, SAT.122 and SBF.101
View official government recall

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