MOSAIQ Oncology Information System — Class II medical device recall Z-0447-2016
Terminated recall by Elekta, Inc., reported 2015-12-23, distributed nationwide. First Databank (FDB) is a third party product incorporated into MOSAIQ. FDB routinely modifies drugs in their
| Recall number | Z-0447-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2015-11-24 |
| Classified | 2015-12-17 |
| Reported by FDA | 2015-12-23 |
| Terminated | 2021-09-15 |
| Distributed | Nationwide (US) |
| Quantity | 211 |
Product
MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery.
Reason for recall
First Databank (FDB) is a third party product incorporated into MOSAIQ. FDB routinely modifies drugs in their database to reflect market and formulary changes. In FDB Framework v2.0, those drugs are not being included in drug-drug, drug-allergy and duplicate drug therapy interaction checking.
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-0447-2016. 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.