Device recall
Z-0757-2017: Ultrasound Video Bronchoscope The EB-1970UK, Ultrasound Video Bronchoscope, is…
FDA device recall · Class II · Pentax of America Inc
Key facts
| Recall number (Z-number) | Z-0757-2017 |
|---|---|
| Recall event | 75249 |
| Product | Ultrasound Video Bronchoscope The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to organs, tissues, and subsystem: Nasal Passage, Pharynx, Larynx… |
| Product code | EOQ |
| Recalling firm | Pentax of America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 19, 2019 |
| 510(k) numbers | K131946 |
| FEI number | 1000080301 |
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