Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
FDA Recall Z-2138-2025 · Posted 2025-07-18
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Recalling FirmNatus Neurology DBA Excel Tech., Ltd. (XLTEK)
Recall StatusOpen, Classified
Product CodeGWQ
Date Initiated2025-06-18
Product Quantity27 units
Reason for Recall
Natus received two complaints of left side labeling show impedance for right side.
Firm Action
Natus issued an Urgent Medical Device Recall notice to its consignees on 06/18/2025 via USPS. The notice explained the issue, risk, and requested the user immediately cease use and quarantine pending return of the unit. A replacement device(s) will be made available to you at no cost, once you provide the completed Customer Reply Form that is listed below and return to [email protected]. Technical Service will be in contact with you to arrange for a provision of replacement device(s).
Root Cause
Process control
Distribution Pattern
US: CA, IN, MO, NC, PA, RI, TX
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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