Device recall
Z-2127-2011: Cirrus HD-OCT Model 4000 instruments, new and refurbished, distributed with, or…
FDA device recall · Class II · Carl Zeiss Meditec Inc
Key facts
| Recall number (Z-number) | Z-2127-2011 |
|---|---|
| Recall event | 58313 |
| Product | Cirrus HD-OCT Model 4000 instruments, new and refurbished, distributed with, or upgraded to, version v 1.0 - 4.5, 5.0.0 or 5.1.0 The Cirrus HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device. |
| Product code | OBO |
| Recalling firm | Carl Zeiss Meditec Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 29, 2012 |
| 510(k) numbers | K083291 |
| FEI number | 2918630 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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