Device recall
Z-2745-2017: 9200C and 9200D Laryngeal Strobe Product Usage: The 9310HD is used to…
FDA device recall · Class II · Pentax of America Inc
Key facts
| Recall number (Z-number) | Z-2745-2017 |
|---|---|
| Recall event | 77137 |
| Product | 9200C and 9200D Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications. |
| Product code | GCW |
| Recalling firm | Pentax of America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 22, 2019 |
| FEI number | 1000080301 |
At a glance
- None Linked 510(k)s
- 1–9 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