Drug recall
Leksell Gamma Knife Icon is a teletherapy device intended for stereotactic irradiation of head structures…
FDA recall event 77291 · Class II · Elekta, Inc.
Key facts
| Event ID | 77291 |
|---|---|
| Recall numbers | Z-2697-2017 |
| Recalling firm | Elekta, Inc. |
| Product type | Devices |
| Products | Leksell Gamma Knife Icon is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters e.g… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | If the gantry module is replaced after original installation the configuration settings may be missing. The identified risk for this issue is electrical safety for technicians doing maintenance on the… |
| Initiation date | May 23, 2017 |
| Report date | Jul 19, 2017 |
| Termination date | Oct 18, 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: