Device recall
Z-0430-2021: Niobe ES System, Models 001-006000-1 and 001-006100-1
FDA device recall · Class II · Stereotaxis Inc
Key facts
| Recall number (Z-number) | Z-0430-2021 |
|---|---|
| Recall event | 86555 |
| Product | Niobe ES System, Models 001-006000-1 and 001-006100-1 |
| Product code | PJB |
| Recalling firm | Stereotaxis Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 13, 2023 |
| 510(k) numbers | K192775 |
| FEI number | 3003084417 |
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