FDA Recall
Open, Classified
Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
Recall: Z-2138-2025
·
Initiated June 18, 2025
Recall
- Recall Number
- Z-2138-2025
- Event Number
- 97091
- Firm
- Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
- FEI Number
- 3002809369
- Product Code
- GWQ
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- June 18, 2025
- Posted
- July 18, 2025
- Address
- 2568 Bristol Cir, Oakville 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.
Action
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 [email protected]. Technical Service will be in contact with you to arrange for a provision of replacement device(s).
Distribution
US: CA, IN, MO, NC, PA, RI, TX
Quantity
27 units