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Recall Observatory FDA recall evidence

Device product

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

Z-2138-2025

June 18, 2025

Class II

Product summary

Firm
Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Event
Event 97091
Status
Ongoing
Classification
Class II
Quantity
27 units
Official record key
device-enforcement:Z-2138-2025

Official wording

Reason: Natus received two complaints of left side labeling show impedance for right side.

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.

Distribution pattern: US: CA, IN, MO, NC, PA, RI, TX

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Natus received two complaints of left side labeling show impedance for right side.