Device recall
Z-1075-2017: Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9108…
FDA device recall · Class II · Pentax of America Inc
Key facts
| Recall number (Z-number) | Z-1075-2017 |
|---|---|
| Recall event | 76089 |
| Product | Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic action with the use of a stroboscopic light source. The instrument is inserted per-orally when indications consistent with the need for observation are observed. |
| Product code | EQL |
| 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