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Inability to retain user default settings on Rad 8 device after power cycle

Reason for Advisory Notice: Rad-8 device has been noted to revert back to factory default settings after power cycle. Device functions as intended once user settings are configured or verified after power cycle, there is no impact to performance. Affected Product: Rad-8 devices that are used with custom configured settings. Impact Assessment: The directions for use for the Rad-8 device...

Important Safety Information on Non-Invasive Ventilation Devices

Non-invasive ventilation devices are used to provide non-invasive respiratory support to patients who experience respiratory insufficiency caused, for instance, by obstructive sleep apnea, chronic obstructive pulmonary disease and neuromuscular or chest wall disorders. The therapy has been increasingly used in the emergency and critical care settings for acutely ill patients. However, Health...