Device recall
Z-1995-2020: Medtronic Nexframe Stereotactic System and StealthStation Cranial software…
FDA device recall · Class I · Medtronic Navigation, Inc.
Key facts
| Recall number (Z-number) | Z-1995-2020 |
|---|---|
| Recall event | 85243 |
| Product | Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License and O-arm Imaging System utilizing the auto-registration (fiducial- less) workflow used in combination during a DBS… |
| Product code | HAW |
| Recalling firm | Medtronic Navigation, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Apr 2, 2024 |
| 510(k) numbers | K153660, 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