Drug recall
Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class of…
FDA recall event 65782 · Class II · Elekta, Inc.
Key facts
| Event ID | 65782 |
|---|---|
| Recall numbers | Z-0138-2014 |
| Recalling firm | Elekta, Inc. |
| Product type | Devices |
| Products | Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class of medical devices that are used in radiotherapy for the treatments of head tumors. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential for clinical errors. |
| Initiation date | Jul 23, 2013 |
| Report date | Nov 13, 2013 |
| Termination date | Nov 18, 2014 |
| 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: