Genio System 2.1
Nyxoah · Model Genio Smartphone Application Software · UDI-DI 05404031000049
MNQ
Prescription
0
510(k) clearances
3,571
Adverse events (4 deaths)
6
Recalls
15
Facilities
Description
The Activation Chip can be controlled by an optional Genio Smartphone Application software, designed to operate on both Android and iOS devices. The Smartphone Application software allows the patient to pause and resume stimulation and to increase/decrease the treatment amplitude within a pre-configured range. The Smartphone Application software uses Bluetooth low energy (BLE) protocol to communicate with a paired Activation Chip.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-11 | Inspire Medical Systems Inc. | Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By D |
| 2026-05-11 | Inspire Medical Systems Inc. | Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By D |
| 2024-07-31 | Inspire Medical Systems Inc. | Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box. |
| 2024-07-31 | Inspire Medical Systems Inc. | Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box. |
| 2024-05-16 | Inspire Medical Systems Inc. | There is a potential manufacturing defect which can lead to electrical leakage in the sensing circuit which causes a system malfunction and requires a revision surgery to replace t |
| 2018-06-12 | Inspire Medical Systems Inc. | Incorrect use-by date on the device registration/patient file labels. |
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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.