Device recall
Z-0009-2018: iFusion, Device Listing Number D203271. Product Usage: The iCam is a…
FDA device recall · Class II · Optovue, Inc.
Key facts
| Recall number (Z-number) | Z-0009-2018 |
|---|---|
| Recall event | 77776 |
| Product | iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions. The iCam takes… |
| Product code | HKI |
| Recalling firm | Optovue, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 12, 2021 |
| 510(k) numbers | K130656 |
| FEI number | 3005950902 |
At a glance
- 1–9 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