Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: Recalled by Natus Neurology DBA Excel Tech., Ltd. (XLTEK) Due to Electrode placement labels on the Digital Acquisition Box...

Date: May 7, 2025
Company: Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Natus Neurology DBA Excel Tech., Ltd. (XLTEK) directly.

Affected 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 Product Description: OBM00002 OBM DAB (Digital Acquisition Box) Component: No

Quantity: 3069

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Natus Neurology DBA Excel Tech., Ltd. (XLTEK)

Natus Neurology DBA Excel Tech., Ltd. (XLTEK) has 7 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report