Device recall
Z-1694-2008: The OptiVantage DH Injection System is a contrast delivery system and is…
FDA device recall · Class II · Mallinckrodt Inc
Key facts
| Recall number (Z-number) | Z-1694-2008 |
|---|---|
| Recall event | 47766 |
| Product | The OptiVantage DH Injection System is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with computed tomography equipment. The J-Bow component is used to connect the powerhead to a suspension… |
| Product code | IZQ |
| Recalling firm | Mallinckrodt Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 20, 2011 |
| 510(k) numbers | K063503 |
| FEI number | 1518293 |
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