Device recall
Z-2737-2024: BrainFeedback Pro 2 Device - is intended as an instrument that provides a visual…
FDA device recall · Class II · RONAN MEDICAL LLC
Key facts
| Recall number (Z-number) | Z-2737-2024 |
|---|---|
| Recall event | 95089 |
| Product | BrainFeedback Pro 2 Device - is intended as an instrument that provides a visual and auditory signal corresponding to the status of a patients physiological parameters so that the patient can control voluntarily these physiological parameters. |
| Product code | HCC |
| Recalling firm | RONAN MEDICAL LLC |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3015497638 |
At a glance
- None 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