Device recall
Z-3067-2017: Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be…
FDA device recall · Class II · Pentax of America Inc
Key facts
| Recall number (Z-number) | Z-3067-2017 |
|---|---|
| Recall event | 77380 |
| Product | Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper… |
| Product code | ODG |
| Recalling firm | Pentax of America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 21, 2020 |
| 510(k) numbers | K061068, K090196 |
| FEI number | 1000080301 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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