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NIHON KOHDEN AMERICA, INC. · Model JL-550T1 · UDI-DI 00841983100697
10
510(k) clearances
3,228
Adverse events (1 deaths)
16
Recalls
88
Facilities
Description
SpO2 adapter
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.