Natus Neurology DBA Excel Tech., Ltd. (XLTEK) 2025-06-18 Health serious FDA
Health · FDA · Recall #FDA-Z-1925-2025
Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB… Recall
Issued June 18, 2025 · Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
In June 2025, Natus Neurology DBA Excel Tech., Ltd. (XLTEK) recalled the Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Natus Neurology DBA Excel Tech., Ltd. (XLTEK) to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
- Category
- Health
- Recall date
- June 18, 2025
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide including Puerto Rico (PR) and OUS (foreign) countries of: Italy (IT), Estonia (EE), Israel (IL), Chi
- Recall number
- FDA-Z-1925-2025
- Made in
- Canada
- Issuing agency
- FDA
In context
- Natus Neurology DBA Excel Tech., Ltd. (XLTEK) has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.