Device recall
Z-0279-2025: AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a…
FDA device recall · Class II · Accriva Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-0279-2025 |
|---|---|
| Recall event | 95497 |
| Product | AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter. |
| Product code | DQA |
| Recalling firm | Accriva Diagnostics, Inc. |
| Recall class | Class II |
| Status | Completed |
| 510(k) numbers | K922075 |
| FEI number | 2250033 |
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