Device recall
Z-0188-2024: StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The…
FDA device recall · Class I · Medtronic Navigation, Inc.
Key facts
| Recall number (Z-number) | Z-0188-2024 |
|---|---|
| Recall event | 93158 |
| Product | StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. The StealthStation FlexENT System, with StealthStation… |
| Product code | HAW |
| Recalling firm | Medtronic Navigation, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K212397 |
| 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