CLASS II ONGOING Device recall · Reported 18 Jun 2025 · FDA Enforcement Report

OBM00002 OBM DAB (Digital Acquisition Box) recalled by Natus Neurology

Natus Neurology is recalling OBM00002 OBM DAB (Digital Acquisition Box), distributed nationwide in the US. The recall was initiated on 7 May 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI 00382830010825 Serial Numbers 001 through OBM00002H3613. Note earlier version serial numbers did not contain the sequence of "OBM"

Quantity recalled3069

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1925-2025
FDA event ID: 96761
Recalling firm: Natus Neurology, Oakville
Classification: Class II
Status: Ongoing
Recall initiated: 7 May 2025
FDA classified: 9 Jun 2025
Reported: 18 Jun 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

7 May 2025	Recall initiated by company
9 Jun 2025	Classified by FDA	+33 days
18 Jun 2025	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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).

Nationwide Arkansas California Colorado Illinois Puerto Rico Tennessee

Questions about this recall

Why was it 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.

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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