Device recall
Z-1776-2024: Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in…
FDA device recall · Class I · Medtronic Navigation, Inc.
Key facts
| Recall number (Z-number) | Z-1776-2024 |
|---|---|
| Recall event | 94411 |
| Product | Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. |
| Product code | HAW |
| Recalling firm | Medtronic Navigation, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K162309 |
| FEI number | 1000517638 |
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