FDA Enforcement
Class II
Ongoing
Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
Recall: Z-2138-2025
·
Reported July 30, 2025
Enforcement
- Recall Number
- Z-2138-2025
- Event ID
- 97091
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 30, 2025
- Initiation Date
- June 18, 2025
- Classification Date
- July 18, 2025
- Address
- 2568 Bristol Cir, N/A, Oakville, N/A, N/A, Canada
Description
Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
Reason
Natus received two complaints of left side labeling show impedance for right side.
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.
Distribution
US: CA, IN, MO, NC, PA, RI, TX
Quantity
27 units