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

2 FDA enforcement actions

2 Total Recalls

0 Class I

2 Class II

0 Class III

Firm Details

Product Types: device
States: N/A

All Recalls

Class II: Risk 06/18/2025 device

Natus received two complaints of left side labeling show impedance for right side.
Class II: Risk 05/07/2025 device

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.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.