Medical device recalls Moderate risk

Natus Neurology DBA Excel Tech., Ltd. (XLTEK) recalls Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph

Recall date
June 18, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2138-2025
FDA classification
Class II
Brand / firm
Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Sold / distributed
US: CA, IN, MO, NC, PA, RI, TX

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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