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NATUS NEUROLOGY

NATUS NEUROLOGY INCORPORATED · Model DM-842-128400 · UDI-DI 00382830032001

GWF Prescription
1
510(k) clearances
3,228
Adverse events (1 deaths)
16
Recalls
88
Facilities

Description

DESKTOP COMPUTER/ENDEAVOR CR - Demo

Recalls

DateFirmReason
2026-05-13Alphatec Spine, Inc.Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as sys
2025-03-10Medtronic Xomed, Inc.Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation
2024-06-24Medtronic Xomed, Inc.Potential for false negative response on the NIM Vital Nerve Monitoring System
2024-05-17Cadwell Industries IncElectroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resulting in unintended electrical sti
2024-04-23Cadwell Industries IncThere is the potential that an electroneurodiagnostic medical device insulator may be installed incorrectly which could result in arcing to patient connections resulting in potenti
2022-05-03Medtronic Xomed, Inc.Software anomaly was identified.
2022-05-03Medtronic Xomed, Inc.Software anomaly was identified.
2017-03-14Nexstim PLCSoftware defect: the NBS software may accidentally generate duplicate copies of one or several files.
2017-03-14Nexstim PLCSoftware defect: the NBS software may accidentally generate duplicate copies of one or several files.
2015-01-02Natus Medical IncorporatedSoftware error occurs when using remote monitoring; if the remote user tries to stop the free run waveform group, the system will display a message informing the user that they do

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.