Device recall
Z-1535-2024: AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors…
FDA device recall · Class I · SonarMed Inc
Key facts
| Recall number (Z-number) | Z-1535-2024 |
|---|---|
| Recall event | 94302 |
| Product | AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring. |
| Product code | OQU |
| Recalling firm | SonarMed Inc |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K193058 |
| FEI number | 3009923584 |
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