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Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital A...

FDA Device Recall #Z-1925-2025 — Class II — May 7, 2025

Recall Summary

Recall Number Z-1925-2025
Classification Class II — Moderate risk
Date Initiated May 7, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Location Oakville
Product Type Devices
Quantity 3069

Product Description

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 Pattern

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 Republic (the) (DO), Lebanon (LB), Malaysia (MY), Costa Rica (CR), Viet Nam (VN), & Bahrain (BH).

Lot / Code Information

UDI-DI 00382830010825 Serial Numbers 001 through OBM00002H3613. Note earlier version serial numbers did not contain the sequence of "OBM"

Other Recalls from Natus Neurology DBA Excel Tech., Ltd....

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Z-2138-2025 Class II Natus Brain Monitor Breakout Box, Part Number 0... Jun 18, 2025
Z-0661-2022 Class II IPELA FHD PTZ TILE KITS with Axis cameras used ... Dec 2, 2021
Z-1630-2020 Class II natus newborn care Olympic Brainz Monitor, REF ... Mar 5, 2020
Z-2737-2018 Class II Natus Neurology ErgoJust Carts labeled as the f... May 18, 2018
Z-2570-2018 Class II XLTEK EMU40EX EEG Headbox May 15, 2018

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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