Device recall
Z-1099-2012: Retcam3 & Retcam Shuttle with version 6.0 software. Clarity Medical Systems…
FDA device recall · Class II · Clarity Medical Systems Inc
Key facts
| Recall number (Z-number) | Z-1099-2012 |
|---|---|
| Recall event | 61180 |
| Product | Retcam3 & Retcam Shuttle with version 6.0 software. Clarity Medical Systems, Inc. 5775 W. Las Positas Blvd, Suite 200 Pleasanton, CA 94588 General ophthalmic imaging including retinal, corneal and external imaging. Photodocumentation of pediatric ocular diseases including retinopathy or prematurity… |
| Product code | HKI |
| Recalling firm | Clarity Medical Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 7, 2012 |
| 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