Drug recall
Monaco The Monaco system is used to make treatment plans for patients with prescriptions for external beam…
FDA recall event 68985 · Class II · Elekta, Inc.
Key facts
| Event ID | 68985 |
|---|---|
| Recall numbers | Z-2581-2014 |
| Recalling firm | Elekta, Inc. |
| Product type | Devices |
| Products | Monaco The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Incorrect Delivery of Composite VMAT Fields - When DICOM is exporting an arc plan (VMAT, Dynamic Conformal or 3D Static Arcs) and using the Composite Field Sequencing (CFS) feature, the DICOM exported… |
| Initiation date | Aug 18, 2014 |
| Report date | Sep 10, 2014 |
| Termination date | Sep 15, 2021 |
| 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: