Device recall
Z-0636-2021: Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on…
FDA device recall · Class II · Kowa Optimed Inc
Key facts
| Recall number (Z-number) | Z-0636-2021 |
|---|---|
| Recall event | 86737 |
| Product | Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retinal Cameras - Product Usage: is indicated for acquiring, displaying and storing image data from KOWA s mydriatic and non-mydriatic ophthalmic cameras. |
| Product code | NFJ |
| Recalling firm | Kowa Optimed Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 6, 2022 |
| 510(k) numbers | K190056 |
| FEI number | 2080939 |
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