Device recall
Z-1817-2012: TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an…
FDA device recall · Class II · American Optisurgical Inc
Key facts
| Recall number (Z-number) | Z-1817-2012 |
|---|---|
| Recall event | 61253 |
| Product | TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console provides control over each mode of operation, as well as the user interface via LCD touchscreen and audible tones for confirmation of user… |
| Product code | LFL |
| Recalling firm | American Optisurgical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 15, 2012 |
| 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