Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
Summary
The FDA issued a Class II for Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard elec by Natus Neurology DBA Excel Tech., Ltd. (XLTEK). Reason: Natus received two complaints of left side labeling show impedance for right side..
Details
Source
Device Recall
External ID
Z-2138-2025
Action Date
2025-07-30
Status
Ongoing
Category
device
Product Description
Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
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.
Quantity Affected: 27 units
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
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-18
Company
Oakville, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 122 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Natus Neurology DBA Excel Tech., Ltd. (XLTEK) has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Natus Neurology DBA Excel Tech., Ltd. (XLTEK)) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Natus Neurology DBA Excel Tech., Ltd. (XLTEK) have FDA actions?
Natus Neurology DBA Excel Tech., Ltd. (XLTEK) has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2138-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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