Device recall
Z-0307-2012: Elekta Leksell Gamma Plan Product Usage: Gamma Plan is a computer based system…
FDA device recall · Class II · Elekta, Inc.
Key facts
| Recall number (Z-number) | Z-0307-2012 |
|---|---|
| Recall event | 60125 |
| Product | Elekta Leksell Gamma Plan Product Usage: Gamma Plan is a computer based system designed for Gamma Knife treatment planning. |
| Product code | IWB |
| Recalling firm | Elekta, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 31, 2012 |
| 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