Z-2138-2025Class II

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

Name: Z-2138-2025 Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
Creator: Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Published: 2025-06-18
License: https://open.fda.gov/license/

Natus Medical Incorporated / initiated 2025-06-18 / Open, Classified / root cause: manufacturing process

FDA source

Natus Neurology DBA Excel Tech., Ltd. (XLTEK) began a recall of Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph on 2025-06-18. FDA classified it as Class II and gives the reason as "Natus received two complaints of left side labeling show impedance for right side". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2138-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-18
Posted: 2025-07-18
Recalling firm: Natus Medical Incorporated
Product: Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
Product code: GWQ Full-Montage Standard Electroencephalograph
Reason for recall: Natus received two complaints of left side labeling show impedance for right side.
Root cause tag: manufacturing process
FDA root cause: Process control
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).
Quantity in commerce: 27 units
Distribution: US: CA, IN, MO, NC, PA, RI, TX
Product codes and lots: UDI/DI 038283NA00153ED, Serial Numbers: 021918100008-M, 021918100014-M, 021918100015-M, 021918100017-M, 021918100019-M, 021918100020-M, 021918100021-M, 021918100025-M, 021918100026-M, 021918100028-M, 021918100032-M, 021918100034-M, 021918100036-M, 021918100038-M, 021918100039-M, 021918100040-M, 021918100041-M, 021918100044-M, 021918100046-M, 021918100047-M, 021918100048-M, 021918100049-M, 021918100050-M, 021918100051-M, 021918100052-M, 021918100054-M, 021918100055-M.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2138-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2138-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-30	2025-07-18

Product code GWQ

K180290Class IINatus Brain Monitor AmplifierNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) / cleared 2018-06-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)