Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Ca
FDA device recall Z-1925-2025 · posted 2025-06-09 · Open, Classified
Recall details
- Recalling firm
- Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
- 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.
- Action taken
- On May 7, 2025, the firm began notifying customers through "Urgent Medical Device Recall" letters. Customers are instructed to check their Olympic Brainz Monitor stock and determine if they have any devices with the incorrect label orientation. Immediately cease use of incorrectly labeled product and quarantine until you receive return instructions from Natus. Customers with incorrect product labelling will be provided with replacement device(s). If you have any questions regarding this notice, please contact FCA@Natus.com.
- Root cause
- Employee error
- Status
- Open, Classified
- Product code
- OMA
- Quantity affected
- 3069
- Distribution
- Worldwide distribution - US Nationwide including Puerto Rico (PR) and OUS (foreign) countries of: Italy (IT), Estonia (EE), Israel (IL), China (CN), Germany (DE), Saudi Arabia (SA), Switzerland (CH),
- Date initiated
- 2025-05-07
- Date posted
- 2025-06-09
- Location
- Oakville, Canada
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OLYMPIC BRAINZ MONITOR (K123079) | Excel-Tech Ltd. (Xltek) | 2013-05-08 |