Device recall
Z-1690-2017: 8500M Handheld Pulse Oximeter
FDA device recall · Class II · Nonin Medical, Inc
Key facts
| Recall number (Z-number) | Z-1690-2017 |
|---|---|
| Recall event | 75424 |
| Product | 8500M Handheld Pulse Oximeter |
| Product code | DQA |
| Recalling firm | Nonin Medical, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 12, 2018 |
| 510(k) numbers | K893221 |
| FEI number | 2183646 |
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