Drug recall
natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph
FDA recall event 85189 · Class II · Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Key facts
| Event ID | 85189 |
|---|---|
| Recall numbers | Z-1630-2020 |
| Recalling firm | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) |
| Product type | Devices |
| Products | natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The OBM system functional test (impedance and noise) was not carried out on the affected items prior to release to the customer. The manufacturer cannot attest to the system functionality of the… |
| Initiation date | Mar 5, 2020 |
| Report date | Apr 8, 2020 |
| Termination date | Aug 9, 2021 |
| City | Oakville |
| Country | Canada |
| FEI number | 3002809369 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: