Device recall
Z-1630-2020: natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph
FDA device recall · Class II · Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Key facts
| Recall number (Z-number) | Z-1630-2020 |
|---|---|
| Recall event | 85189 |
| Product | natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph |
| Product code | OMA |
| Recalling firm | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 9, 2021 |
| 510(k) numbers | K123079 |
| FEI number | 3002809369 |
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