Recall Z-2138-2025 ยท GWQ Full-Montage Standard Electroencephalograph
Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
| Date | Jul 18, 2025 (initiated Jun 18, 2025) |
| Status | Open, Classified |
| Reason | Natus received two complaints of left side labeling show impedance for right side. |
| Root cause | Process control |
| 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 FCA@natus.com. Technical Service will be in contact with you to arrange for a provision of replacement device(s). |
| Quantity | 27 units |
| Distribution | US: CA, IN, MO, NC, PA, RI, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180290 | Natus Brain Monitor Amplifier Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek), Jun 14, 2018 |