Device recall
Z-2078-2016: Ureteroscope Intended to provide optical visualization of and therapeutic access…
FDA device recall · Class II · Pentax Medical Company
Key facts
| Recall number (Z-number) | Z-2078-2016 |
|---|---|
| Recall event | 73894 |
| Product | Ureteroscope Intended to provide optical visualization of and therapeutic access to the Urinary Track. This anatomy includes but is not restricted to the organs, tissues and subsystems: Urethra, Bladder and Renal Pelvis. The instrument is introduced via the urethra when indications consistent with… |
| Product code | FGB |
| Recalling firm | Pentax Medical Company |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 21, 2017 |
| 510(k) numbers | K914106 |
| FEI number | 1000080301 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 10–99 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