Device recall
Z-2218-2011: AVOXimeter 1000, AVOXimeter 4000 1000- portable bedside whole blood oximeter…
FDA device recall · Class II · International Technidyne Corp.
Key facts
| Recall number (Z-number) | Z-2218-2011 |
|---|---|
| Recall event | 58549 |
| Product | AVOXimeter 1000, AVOXimeter 4000 1000- portable bedside whole blood oximeter that directly measures oxyhemoglobin fraction, the total hemoglobin concentration, and oxygen content. It has enhanced software that optimizes its use int he cardiac catheterization laboratory through calculations of… |
| Product code | DQA |
| Recalling firm | International Technidyne Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 25, 2012 |
| 510(k) numbers | K951485 |
| FEI number | 1000526865 |
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