Device recall
Z-1412-2019: Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based…
FDA device recall · Class II · Elekta Instrument AB
Key facts
| Recall number (Z-number) | Z-1412-2019 |
|---|---|
| Recall event | 82662 |
| Product | Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning. |
| Product code | IWB |
| Recalling firm | Elekta Instrument AB |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K173791 |
| FEI number | 3002806883 |
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