Device recall
Z-1338-2023: Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term…
FDA device recall · Class II · Moberg Research, Inc.
Key facts
| Recall number (Z-number) | Z-1338-2023 |
|---|---|
| Recall event | 91782 |
| Product | Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term neurological monitoring system that collects, displays, and stores multiple physiological measurements Model: CNS-350 |
| Product code | OMA |
| Recalling firm | Moberg Research, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K080217 |
| FEI number | 3007880955 |
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