Natus Neurology DBA Excel Tech., Ltd. (XLTEK) FDA Recalls

3 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalographClass IIJun 18, 2025Natus received two complaints of left side labeling show imp	Natus received two complaints of left side labeling show impedance for right side.	Class IIDevices	Jun 18, 2025
Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Class IIMay 7, 2025Electrode placement labels on the Digital Acquisition Box (D	Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ultimately le	Class IIDevices	May 7, 2025
IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks softwareClass IIDec 2, 2021Tile kits that allow one to install and situate a video came	Tile kits that allow one to install and situate a video camera within a patient environment are not fitting pr	Class IIDevices	Dec 2, 2021