Device recall
Z-2728-2017: Nicolet Elite 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300. Intended for…
FDA device recall · Class II · Natus Neurology Inc
Key facts
| Recall number (Z-number) | Z-2728-2017 |
|---|---|
| Recall event | 77569 |
| Product | Nicolet Elite 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc. |
| Product code | JAF |
| Recalling firm | Natus Neurology Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 22, 2020 |
| 510(k) numbers | K982635 |
| FEI number | 3010611950 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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