FDA Enforcement
Class II
Terminated
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.
Recall: Z-2109-2018
·
Reported June 13, 2018
Enforcement
- Recall Number
- Z-2109-2018
- Event ID
- 80219
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Ion Beam Applications S.A.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 13, 2018
- Initiation Date
- October 28, 2016
- Classification Date
- June 7, 2018
- Termination Date
- August 9, 2019
- Address
- Chemin du Cyclotron, 3, N/A, Louvain La Neuve, N/A, N/A, Belgium
Description
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 Info
Affected units: SAT.123, SAT.126, PAT.115, SAT.122 and SBF.101
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.
Quantity
5 units (12C)