Drug recall
FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contouring and viewing of…
FDA recall event 68984 · Class II · Elekta, Inc.
Key facts
| Event ID | 68984 |
|---|---|
| Recall numbers | Z-2574-2014 |
| Recalling firm | Elekta, Inc. |
| Product type | Devices |
| Products | FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contouring and viewing of treatment plan outputs. Also able to perform CT simulations and forward their information to the… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | When DICOM is exporting an arc plan (VMAT, Dynamic Conformal of 3D Static Arcs) and using the Composite Field Sequencing (CFS) feature, the DICOM exported plan will not match the approved treatment… |
| Initiation date | Aug 18, 2014 |
| Report date | Sep 10, 2014 |
| Termination date | Aug 8, 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: