Class II

Medical Device Recall: Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph

Natus Neurology DBA Excel Tech., Ltd. (XLTEK) · June 18, 2025

Reason for Recall

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

Distribution

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

States Affected

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

Quantity Affected

27 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2138-2025

Status: ongoing

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