Device recall
Z-2043-2008: Innova 2121-1Q/3131-1Q is a Biplane Cardiovascular Imaging System. The Innova…
FDA device recall · Class II · GE Healthcare
Key facts
| Recall number (Z-number) | Z-2043-2008 |
|---|---|
| Recall event | 46796 |
| Product | Innova 2121-1Q/3131-1Q is a Biplane Cardiovascular Imaging System. The Innova Biplane systems are the first and only digital flat panel biplane system with a full sized lateral plane to cover lateral anatomy without requiring multiple contrast injections and radiation exposures. |
| Product code | MQB |
| Recalling firm | GE Healthcare |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 17, 2011 |
| 510(k) numbers | K061163 |
| FEI number | 2126677 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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