# FDA recall Z-1925-2025

> **Natus Neurology DBA Excel Tech., Ltd. (XLTEK)** · Class II · device recall initiated 2025-05-07.

## 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

## 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.

## 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), Chile (CL), Colombia (CO), Netherlands (the) (NL), Japan (JP), United Kingdom of Great Britain and Northern Ireland(the) (GB), Russian Federation (the)(RU), Bolivia (Plurinational State of) (BO), Canada (CA), France (FR), Peru (PE), Guyana (GY), Mexico (MX), Belgium (BE), Thailand (TH), Paraguay (PY), Hong Kong (HK), United Arab Emirates (AE), Austria (AT), India (IN), Indonesia (ID), Kuwait (KW), Qatar (QA), Lithuania (LT), Denmark (DK), Myanmar (MM), Uruguay (UY), Tunisia (TN), Turkey (TR), Korea (the Republic of) (KR), Hungary (HU), Slovenia (SI), Argentina (AR), Norway (NO), Oman (OM), Poland (PL), Finland (FI), Ireland (IE), Australia (AU), Latvia (LV), Ecuador (EC), Singapore (SG), Spain (ES), Serbia (RS), South Africa (ZA), Romania (RO), Algeria (DZ), Portugal (PT), Dominican Republ

## Key facts

- **Recall number:** Z-1925-2025
- **Recalling firm:** Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-07
- **Report date:** 2025-06-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Oakville, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1925-2025

## Citation

> AI Analytics. FDA recall Z-1925-2025. Retrieved 2026-06-11 from https://api.ai-analytics.org/recall/Z-1925-2025. Source: US FDA. Licensed CC0.

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