Device recall
Z-1604-2010: Leksell GammaPlan 8.0 image fusion Leksell GammaPlan is designed for use with…
FDA device recall · Class II · Elekta, Inc.
Key facts
| Recall number (Z-number) | Z-1604-2010 |
|---|---|
| Recall event | 54890 |
| Product | Leksell GammaPlan 8.0 image fusion Leksell GammaPlan is designed for use with the Leksell Gamma Knife manufactured by Elekta Instrument AB. the Leksell GammaPlan is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. It… |
| Product code | IWB |
| Recalling firm | Elekta, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 28, 2010 |
| 510(k) numbers | K973441 |
| 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