Neuro-IOM
NEUROSOFT, OOO · Model Neuro-IOM · UDI-DI 04650075330371
Description
Neuro-IOM system with Neuro-IOM.NET software is a medical device intended for intraoperative neurophysiologic monitoring: the device provides information to assess a patient’s neurophysiological status. The system allows to monitor the functional integrity and/or mapping of central and peripheral nervous system including motor and sensory pathways. It is provided in III different configurations: I. 32/B II. 32/S III. 16/S The system ensures the following IOM modalities: free-run EMG (electromyography), direct nerve stimulation including pedicle screw test, SSEP (somatosensory evoked potentials), MEP (motor evoked potentials), EEG (electroencephalography), AEP (au-ditory evoked potentials), VEP (visual evoked potentials), direct cortical stimulation. Also the train-of-four (TOF) stimulation is performed. The system is not intended to measure the vital signs. It records the data to be inter-preted by the neuromonitoring specialist.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-13 | Alphatec 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 |
| 2025-03-10 | Medtronic 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 |
| 2024-06-24 | Medtronic Xomed, Inc. | Potential for false negative response on the NIM Vital Nerve Monitoring System |
| 2024-05-17 | Cadwell Industries Inc | Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resulting in unintended electrical sti |
| 2024-04-23 | Cadwell Industries Inc | There is the potential that an electroneurodiagnostic medical device insulator may be installed incorrectly which could result in arcing to patient connections resulting in potenti |
| 2022-05-03 | Medtronic Xomed, Inc. | Software anomaly was identified. |
| 2022-05-03 | Medtronic Xomed, Inc. | Software anomaly was identified. |
| 2017-03-14 | Nexstim PLC | Software defect: the NBS software may accidentally generate duplicate copies of one or several files. |
| 2017-03-14 | Nexstim PLC | Software defect: the NBS software may accidentally generate duplicate copies of one or several files. |
| 2015-01-02 | Natus Medical Incorporated | Software 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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