OBM00002 OBM DAB (XLTEK) – Backwards Electrode Labels (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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 Product Description: OBM00002 OBM DAB (Digital Acquisition Box) Component: No
Brand
Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
UDI-DI 00382830010825 Serial Numbers 001 through OBM00002H3613. Note earlier version serial numbers did not contain the sequence of "OBM"
Natus Neurology DBA Excel Tech., Ltd. (XLTEK) is recalling Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acqui due to Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ultimately lead to misdiagnosis of seizure location i. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026