Drug recall
Monaco radiation therapy treatment planning system. The Monaco system is used to make treatment plans for…
FDA recall event 70434 · Class II · Elekta, Inc.
Key facts
| Event ID | 70434 |
|---|---|
| Recall numbers | Z-1237-2015 |
| Recalling firm | Elekta, Inc. |
| Product type | Devices |
| Products | Monaco radiation therapy treatment planning system. The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Incorrect CT to ED when using the Monaco Image Statistics Tool. |
| Initiation date | Dec 19, 2014 |
| Report date | Mar 11, 2015 |
| Termination date | Nov 17, 2017 |
| City | Atlanta |
| State | GA |
| Country | United States |
| FEI number | 1037831 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: