Device recall
Z-2697-2017: Leksell Gamma Knife Icon is a teletherapy device intended for stereotactic…
FDA device recall · Class II · Elekta, Inc.
Key facts
| Recall number (Z-number) | Z-2697-2017 |
|---|---|
| Recall event | 77291 |
| Product | 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., metastatic tumors, recurrent glioblastomas, trigeminal neuralgia, medically refractory essential tremor… |
| Product code | IWB |
| Recalling firm | Elekta, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 18, 2017 |
| 510(k) numbers | K160440 |
| FEI number | 1037831 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database