Device recall
Z-2129-2016: PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control Box…
FDA device recall · Class II · Medtronic Navigation
Key facts
| Recall number (Z-number) | Z-2129-2016 |
|---|---|
| Recall event | 74464 |
| Product | PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control Box Cables, Thermoflex Chiller Product The PoleStar Surgical MRI System is intended for use as an intraoperative imaging device to produce MRI images of sections of the head selected by the physician. |
| Product code | LNH |
| Recalling firm | Medtronic Navigation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 21, 2017 |
| 510(k) numbers | K032541 |
| FEI number | 3003348378 |
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