Drug recall
Agility. Version 3.0 of the Integrity interface and control software for the Elekta range of medical digital…
FDA recall event 67184 · Class II · Elekta, Inc.
Key facts
| Event ID | 67184 |
|---|---|
| Recall numbers | Z-1083-2014, Z-1084-2014, Z-1085-2014 |
| Recalling firm | Elekta, Inc. |
| Product type | Devices |
| Products | Agility. Version 3.0 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators., Agility. Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators., Integrity. Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value. |
| Initiation date | Nov 25, 2013 |
| Report date | Mar 12, 2014 |
| Termination date | Nov 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: