Genio System 2.1
Nyxoah · Model Genio Charging Unit Model #2238 · UDI-DI 05404031024823
MNQ
Prescription
0
510(k) clearances
3,571
Adverse events (4 deaths)
6
Recalls
15
Facilities
Description
The Charging Unit and its power adapter are used to recharge the Activation Chip battery during the day in order to be ready for use the following night. The Charging Unit is comprised of a docking area to plug the Activation Chip in, a power LED indicator and a micro-USB port to connect to the power adapter.
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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.