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MEGA-TMS
NEUROSOFT, OOO · Model MEGA-TMS · UDI-DI 04650075333174
1
510(k) clearances
3,308
Adverse events (1 deaths)
16
Recalls
87
Facilities
Description
The device is intended for magnetic stimulation of peripheral nerves. The obtained responses of stimulated structures can be recorded with EMG system for further diagnostic evaluation.
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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Get your free API keyRead the docsData 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.