FDA Medical Device Recalls (openFDA)
Natus Neurology DBA Excel Tech., Ltd. (XLTEK): Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
- Recall number
- Z-2138-2025
- Recalling firm
- Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
- Product
- Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
- Status
- Open, Classified
- Initiated
- 2025-06-18
- Posted
- 2025-07-18
- Terminated
- not on file
- Reason
- Natus received two complaints of left side labeling show impedance for right side.
- 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 FCA@natus.com. Technical Service will be in contact with you to arrange for a provision of replacement device(s).
- Quantity
- 27 units
- Distribution
- US: CA, IN, MO, NC, PA, RI, TX
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K180290"]
- PMA numbers
- not on file
- Product code
- GWQ
- Firm FEI
- 3002809369
- Firm city
- Oakville
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28