Device recall
Z-0301-2017: FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch"…
FDA device recall · Class II · Lumenis Limited
Key facts
| Recall number (Z-number) | Z-0301-2017 |
|---|---|
| Recall event | 75384 |
| Product | FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional treatments in gynecology. |
| Product code | GEX |
| Recalling firm | Lumenis Limited |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 11, 2017 |
| 510(k) numbers | K100415 |
| FEI number | 3004135191 |
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