Device recall
Z-0715-2011: Polaris Spectra System Control Unit, a component of the StealthStation S7…
FDA device recall · Class II · Medtronic Navigation, Inc
Key facts
| Recall number (Z-number) | Z-0715-2011 |
|---|---|
| Recall event | 57277 |
| Product | Polaris Spectra System Control Unit, a component of the StealthStation S7 System. Medtronic Navigation, Louisville, CO 80027. Intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. |
| Product code | HAW |
| Recalling firm | Medtronic Navigation, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 3, 2011 |
| 510(k) numbers | K050438 |
| 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