Device recall
Z-2048-2009: Stratus OCT Model 3000 instruments distributed with version 6.0.0 software…
FDA device recall · Class II · Carl Zeiss Meditec Inc
Key facts
| Recall number (Z-number) | Z-2048-2009 |
|---|---|
| Recall event | 52993 |
| Product | Stratus OCT Model 3000 instruments distributed with version 6.0.0 software, product number 2660021119710 (new instrument) or 2660022119710 (refurbished instrument), and Stratus 6.0.0 Software Kit, product number 2660021133164. The Stratus OCT is a high resolution tomographic device for the viewing… |
| Product code | HLI |
| Recalling firm | Carl Zeiss Meditec Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 19, 2010 |
| 510(k) numbers | K030433, K033123 |
| FEI number | 2918630 |
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