Device recall
Z-1154-2014: RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical…
FDA device recall · Class II · Clarity Medical Systems Inc
Key facts
| Recall number (Z-number) | Z-1154-2014 |
|---|---|
| Recall event | 67470 |
| Product | RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588. General ophthalmic imaging including retinal, corneal and external imaging. |
| Product code | HKI |
| Recalling firm | Clarity Medical Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 11, 2014 |
| 510(k) numbers | K081858, K090326, K102859 |
| FEI number | 3004014430 |
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