Natus Neurology DBA Excel Tech., Ltd. (XLTEK) Recalls
2 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.
Medical Device Recalls (2)
- Class II
June 18, 2025
Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
Natus received two complaints of left side labeling show impedance for right side.
- Class II
May 7, 2025
Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box) Software Version: N/
Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ultimately lead to misdiagnosis of seizure location in neonates monitored with this device.
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