Natus Neurology DBA Excel Tech., Ltd. (XLTEK) — Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
⚠️ Natus received two complaints of left side labeling show impedance for right side.
Is this relevant to me?
- Geography
- US, CA, IN, MO, NC, PA, RI, TX
- Source agency
- FDA
- Category
- Health
- Published
- June 18, 2025
US: CA, IN, MO, NC, PA, RI, TX
What's affected?
- Product
- Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
- Lot code
- 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.
Additional details
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.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 27 units.
Get Health recall alerts
Delivered to your inbox. Free. No account required.