Device recall
Z-1265-2014: Halogen Lamp component in RetCam 3 System - Clarity Medical Systems, Inc…
FDA device recall · Class II · Clarity Medical Systems Inc
Key facts
| Recall number (Z-number) | Z-1265-2014 |
|---|---|
| Recall event | 67702 |
| Product | Halogen Lamp component in RetCam 3 System - Clarity Medical Systems, Inc; Pleasanton, CA. General ophthalmic imaging including retinal, corneal and external imaging. Photo-documentation of pediatric ocular diseases including retinopathy of prematurity. Screening for Type-2 re-threshold retinopathy… |
| Product code | HKI |
| Recalling firm | Clarity Medical Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 11, 2014 |
| 510(k) numbers | K081858 |
| 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