FDA Device recall Z-0447-2016
MOSAIQ Oncology Information System
- FDA Device
- Class II
- terminated
- Published 2015-12-23
On 2015-12-23 the FDA classified a Class II recall of MOSAIQ Oncology Information System by Elekta, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0447-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-24 |
| Published | 2015-12-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Elekta |
| Distribution | US |
Product
MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery.
Reason
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.
Identifiers
| code_info | Versions prior to 2.60. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0447-2016%22
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