Device recall
Z-1519-2008: GE Healthcare Innova 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular…
FDA device recall · Class II · Datex - Ohmeda, Inc
Key facts
| Recall number (Z-number) | Z-1519-2008 |
|---|---|
| Recall event | 48977 |
| Product | GE Healthcare Innova 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular imaging system). The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging… |
| Product code | MQB |
| Recalling firm | Datex - Ohmeda, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 9, 2009 |
| 510(k) numbers | K050489, K052157, K052412 |
| FEI number | 2183066 |
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