Device recall
Z-2866-2017: OptiLITE(TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F…
FDA device recall · Class II · Xintec Corp
Key facts
| Recall number (Z-number) | Z-2866-2017 |
|---|---|
| Recall event | 77653 |
| Product | OptiLITE(TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F, HTM1060F, HTM1010F; Manufactured by CONVERGENT LASTER TECHNOLOGIES The Odyssey 30B is approved for numerous medical procedures. Generally, the primary use of the laser (which includes the fibers) is related to urology, but… |
| Product code | GEX |
| Recalling firm | Xintec Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 20, 2018 |
| 510(k) numbers | K992866 |
| FEI number | 2938889 |
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