Device recall
Z-3099-2024: Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF…
FDA device recall · Class II · Zoe Medical Incorporated
Key facts
| Recall number (Z-number) | Z-3099-2024 |
|---|---|
| Recall event | 95160 |
| Product | Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331 |
| Product code | DQA |
| Recalling firm | Zoe Medical Incorporated |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K150620 |
| FEI number | 3003294644 |
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