Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
FDA device recall Z-2138-2025 · posted 2025-07-18 · Open, Classified
Recall details
- Recalling firm
- Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
- Reason for recall
- Natus received two complaints of left side labeling show impedance for right side.
- Action taken
- Natus issued an Urgent Medical Device Recall notice to its consignees on 06/18/2025 via USPS. The notice explained the issue, risk, and requested the user immediately cease use and quarantine pending return of the unit. A replacement device(s) will be made available to you at no cost, once you provide the completed Customer Reply Form that is listed below and return to FCA@natus.com. Technical Service will be in contact with you to arrange for a provision of replacement device(s).
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- GWQ
- Quantity affected
- 27 units
- Distribution
- US: CA, IN, MO, NC, PA, RI, TX
- Date initiated
- 2025-06-18
- Date posted
- 2025-07-18
- Location
- Oakville, Canada
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Natus Brain Monitor Amplifier (K180290) | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2018-06-14 |