Device recall
Z-0383-2022: Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or…
FDA device recall · Class I · Medtronic Navigation, Inc.
Key facts
| Recall number (Z-number) | Z-0383-2022 |
|---|---|
| Recall event | 89058 |
| Product | Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy Cranial, Model: 9733763, and StealthStation Cranial, Model: 9735585 |
| Product code | HAW |
| Recalling firm | Medtronic Navigation, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K150216, K190672 |
| 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