FDA recall Z-2138-2025
Natus Neurology DBA Excel Tech., Ltd. (XLTEK) · Class II · device
Product
Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
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
Key facts
- Status
- Ongoing
- Initiation date
- 2025-06-18
- Report date
- 2025-07-30
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Oakville, N/A, Canada
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2138-2025