Recall database

Amplitude-Integrated Electroencephalograph recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–1 of 1 recalls

Class IIOngoingZ-1925-2025

Natus Neurology DBA Excel Tech., Ltd. (XLTEK) recalls Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB…

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.

Amplitude-Integrated Electroencephalograph
Employee error

Natus Neurology DBA Ex…Jun 18, 2025