Device recall
Z-0540-2010: GE Healthcare, Innova 2121-1Q/3131-1Q Biplane Cardiovascular Imaging Systems…
FDA device recall · Class II · GE Medical Systems, LLC
Key facts
| Recall number (Z-number) | Z-0540-2010 |
|---|---|
| Recall event | 53596 |
| Product | GE Healthcare, Innova 2121-1Q/3131-1Q Biplane Cardiovascular Imaging Systems. Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational angiography procedures. They are also indicated for… |
| Product code | MQB |
| Recalling firm | GE Medical Systems, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 4, 2012 |
| 510(k) numbers | K060259 |
| 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