Recall Z-2138-2025— Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Class II · Ongoing
Class II FDA medical device recall by Natus Neurology DBA Excel Tech., Ltd. (XLTEK), initiated 2025-06-18. It names one FDA 510(k) clearance: K180290. Product: 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..
- Recalling firm
- Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-06-18
- Firm location
- Oakville, N/A, Canada
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.