Device recall
Z-0934-2021: Neuroreader Medical Image Processing Software - Product Usage: intended to…
FDA device recall · Class II · Brainreader ApS
Key facts
| Recall number (Z-number) | Z-0934-2021 |
|---|---|
| Recall event | 86995 |
| Product | Neuroreader Medical Image Processing Software - Product Usage: intended to automate the current manual process of identifying, labeling, and quantifying the volume of segmentable brain structures identified on MR images. |
| Product code | LLZ |
| Recalling firm | Brainreader ApS |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 12, 2021 |
| 510(k) numbers | K140828 |
| FEI number | 3011657336 |
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