Device recall
Z-0934-2012: Imalux Niris OCT Imaging System Probe, Model Number 1300, Serial Number F464019…
FDA device recall · Class III · Imalux Corporation
Key facts
| Recall number (Z-number) | Z-0934-2012 |
|---|---|
| Recall event | 60911 |
| Product | Imalux Niris OCT Imaging System Probe, Model Number 1300, Serial Number F464019, IMALUX Corporation, Cleveland, OH The Niris Imaging System probe is used with the Niris Imaging System. The Niris Imaging System employs Optical Coherence Tomography (OCT), which can be used to construct high spatial… |
| Product code | NQQ |
| Recalling firm | Imalux Corporation |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jan 9, 2014 |
| 510(k) numbers | K042894 |
| FEI number | 3003883695 |
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