FDA Device recall Z-2109-2018
12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged particle or photon radiation therapy…
- FDA Device
- Class II
- terminated
- Published 2018-06-13
On 2018-06-13 the FDA classified a Class II recall of 12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged particle or photon radiation therapy… by Ion Beam Applications, citing IBA is initiating this recall to address an issue identified with AdaPTinsight software and to reduce risk related to this problem.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2109-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-28 |
| Published | 2018-06-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ion Beam Applications |
| Distribution | US |
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.
Reason
IBA is initiating this recall to address an issue identified with AdaPTinsight software and to reduce risk related to this problem.
Identifiers
| code_info | Affected units: SAT.123, SAT.126, PAT.115, SAT.122 and SBF.101 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2109-2018%22
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