Device recall
Z-2074-2016: Naso-Pharyngo-Laryngoscope Intended to provide optical visualization of…
FDA device recall · Class II · Pentax Medical Company
Key facts
| Recall number (Z-number) | Z-2074-2016 |
|---|---|
| Recall event | 73894 |
| Product | Naso-Pharyngo-Laryngoscope Intended to provide optical visualization of, therapeutic access to, the Upper Airway. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Ear, Nasal Passage and Trachea. The instrument is introduced via the mouth or the nose, as decided by… |
| Product code | EOB |
| Recalling firm | Pentax Medical Company |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 21, 2017 |
| 510(k) numbers | K921707 |
| FEI number | 1000080301 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 1–9 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