Device recall
Z-2076-2016: Ultrasound Bronchoscope Intended to provide optical visualization of, ultrasonic…
FDA device recall · Class II · Pentax Medical Company
Key facts
| Recall number (Z-number) | Z-2076-2016 |
|---|---|
| Recall event | 73894 |
| Product | Ultrasound Bronchoscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Pulmonary Tract including but not restricted to organs, tissues and subsystems: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem)… |
| Product code | EOQ |
| Recalling firm | Pentax Medical Company |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 21, 2017 |
| 510(k) numbers | K023376, K131028, K951199 |
| FEI number | 1000080301 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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