Z-1925-2025Class II

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

Name: Z-1925-2025 Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition...
Creator: Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Published: 2025-05-07
License: https://open.fda.gov/license/

Natus Medical Incorporated / initiated 2025-05-07 / Open, Classified / root cause: manufacturing process

FDA source

Natus Neurology DBA Excel Tech., Ltd. (XLTEK) began a recall of Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Catalog Number: OBM00002 OBM DAB (Digital... on 2025-05-07. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1925-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-07
Posted: 2025-06-09
Recalling firm: Natus Medical Incorporated
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
Product code: OMA Amplitude-Integrated Electroencephalograph
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: 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 [email protected].
Quantity in commerce: 3069
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 Republic (the) (DO), Lebanon (LB), Malaysia (MY), Costa Rica (CR), Viet Nam (VN), & Bahrain (BH).
Product codes and lots: UDI-DI 00382830010825 Serial Numbers 001 through OBM00002H3613. Note earlier version serial numbers did not contain the sequence of "OBM"

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1925-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1925-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-09

Product code OMA

K123079Class IIOlympic Brainz MonitorExcel-Tech Ltd. (Xltek) / cleared 2013-05-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)