Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
This recall is currently active, issued July 18, 2025. It was issued by Natus Neurology Dba Excel Tech., Ltd. (Xltek).
- Recall Initiated
- June 18, 2025
- Posted
- July 18, 2025
- Recall Number
- Z-2138-2025
- Quantity
- 27 units
- Firm Location
- Oakville Canada
- Official Source
- View on FDA website ↗
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
Lot / Code Info
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.
Root Cause
Process control
Action Taken
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).