Drug recall
Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition…
FDA recall event 96761 · Class II · Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Key facts
| Event ID | 96761 |
|---|---|
| Recall numbers | Z-1925-2025 |
| Recalling firm | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) |
| Product type | Devices |
| Products | Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box) Software Version: N/A… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ultimately lead to misdiagnosis of seizure location in neonates monitored with this device. |
| Initiation date | May 7, 2025 |
| Report date | Jun 18, 2025 |
| 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: