Natus Neurology DBA Excel Tech., Ltd. (XLTEK): Device Recall

Recall #Z-2138-2025 · 06/18/2025

Class II: Risk

Recall Details

Recall Number: Z-2138-2025
Classification: Class II
Product Type: Device
Recalling Firm: Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Status: Ongoing
Date Initiated: 06/18/2025
Location: Oakville, N/A, Canada
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 27 units

Reason for Recall

Natus received two complaints of left side labeling show impedance for right side.

Product Description

Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph

Distribution Pattern

US: CA, IN, MO, NC, PA, RI, TX

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

Class II: Risk 05/07/2025

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.

View all recalls by Natus Neurology DBA Excel Tech., Ltd. (XLTEK) →

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.