Device recall
Z-1516-2013: American Optisurgical's TX1 Tissue Removal System Console. The console is a…
FDA device recall · Class II · American Optisurgical Inc
Key facts
| Recall number (Z-number) | Z-1516-2013 |
|---|---|
| Recall event | 65113 |
| Product | American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures. |
| Product code | LFL |
| Recalling firm | American Optisurgical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 24, 2014 |
| 510(k) numbers | K101561 |
| FEI number | 1000135560 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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