12C — Class II medical device recall Z-2109-2018
Terminated recall by Ion Beam Applications S.A., reported 2018-06-13, distributed nationwide. IBA is initiating this recall to address an issue identified with AdaPTinsight software and to reduce risk rel
| Recall number | Z-2109-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ion Beam Applications S.A., Louvain La Neuve, N/A, Belgium |
| Recall initiated | 2016-10-28 |
| Classified | 2018-06-07 |
| Reported by FDA | 2018-06-13 |
| Terminated | 2019-08-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | FR, IT, SE |
| Reason classes | software |
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 for recall
IBA is initiating this recall to address an issue identified with AdaPTinsight software and to reduce risk related to this problem.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2109-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.