Device recall
Z-0918-2012: NanoKnife Irreversible Electroporation System. System consists of multiple…
FDA device recall · Class II · Angiodynamics Worldwide Headquarters
Key facts
| Recall number (Z-number) | Z-0918-2012 |
|---|---|
| Recall event | 60707 |
| Product | NanoKnife Irreversible Electroporation System. System consists of multiple components: Generator, footswitch, disposable electrode. System is manufactured by AngioDynamics, Inc. --- Catalog #20300101 Intended use: the generator system with six outputs is indicated for surgical ablation of soft… |
| Product code | OAB |
| Recalling firm | Angiodynamics Worldwide Headquarters |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 10, 2016 |
| 510(k) numbers | K080202 |
| FEI number | 3008319439 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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