Reported Jun 18, 2025 · Ongoing
Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box)…
Natus Neurology dba Excel Tech., Ltd. (XLTEK)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Natus Neurology DBA Excel Tech., Ltd. (XLTEK) · 2568 Bristol Cir · Oakville · N/A
Is this the product you have?
- Brand NameOBM00002 OBM DAB (Digital
- Acquisition Box) Product NameOBM00002 OBM DAB (Digital
- Acquisition Box) Model/Catalog NumberOBM00002 OBM DAB (Digital
- Acquisition Box) Software VersionN/A
- Product DescriptionOBM00002 OBM
- DAB (Digital Acquisition Box) ComponentNo
- Lot codes and dates
- UDI-DI 00382830010825 Serial Numbers 001 through OBM00002H3613. Note earlier version serial numbers did not contain the sequence of "OBM"
- Amount recalled
- 3069
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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