Device recall
Z-3143-2024: Seer Home System is an ambulatory electroencephalograph (EEG) system intended…
FDA device recall · Class II · SEER MEDICAL PTY LTD
Key facts
| Recall number (Z-number) | Z-3143-2024 |
|---|---|
| Recall event | 95138 |
| Product | Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video EEG (vEEG) recordings and analysis. The Seer Home System includes the Sight Monitoring Hub, the Sense wearable, Monitoring Portal and associated accessory components (Disposable… |
| Product code | GWQ |
| Recalling firm | SEER MEDICAL PTY LTD |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K212788 |
| FEI number | 3017937309 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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