Device recall
Z-1068-2015: EPWorks software used in the Xltek Protektor Stimulator Product Usage…
FDA device recall · Class II · Natus Medical Incorporated
Key facts
| Recall number (Z-number) | Z-1068-2015 |
|---|---|
| Recall event | 70157 |
| Product | EPWorks software used in the Xltek Protektor Stimulator Product Usage: Intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency. |
| Product code | GWF |
| Recalling firm | Natus Medical Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 22, 2017 |
| 510(k) numbers | K040358 |
| FEI number | 3002809369 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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