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U.S. Department of Health and Human Services

Class 2 Device Recall Natus Brain Monitor Breakout Box

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 Class 2 Device Recall Natus Brain Monitor Breakout Boxsee related information
Date Initiated by FirmJune 18, 2025
Date PostedJuly 18, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2138-2025
Recall Event ID 97091
510(K)NumberK180290 
Product Classification Full-montage Standard Electroencephalograph - Product Code GWQ
ProductNatus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
Code Information 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.
Recalling Firm/
Manufacturer		 Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
2568 Bristol Cir
Oakville Canada
Manufacturer Reason
for Recall		Natus received two complaints of left side labeling show impedance for right side.
FDA Determined
Cause 2		Process control
ActionNatus 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 in Commerce27 units
DistributionUS: CA, IN, MO, NC, PA, RI, TX
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = GWQ
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