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Genio System 2.1

Nyxoah · Model Genio Sleep Lab Application Software · UDI-DI 05404031000025

MNQ Prescription

510(k) clearances

3,666

Adverse events (4 deaths)

Recalls

Facilities

Description

The Genio Sleep Lab Application software is used to configure the Activation Chip stimulation parameters. This remote application runs on a small mini-computer (Repeater, provided as part of the Genio Sleep Lab Kit - Primary DI: 05404031025301) and uses Bluetooth low energy (BLE) protocol to enable the operator to configure/customize the Activation Chip stimulation parameters. Once the Activation Chip is connected to a Disposable Patch, the Sleep Lab Application can be used to perform Activation Chip check-ups, read usage data stored in the AC and program/adjust the stimulation parameters.

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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Data 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.