Noah Medical recalls Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access…

Bronchoscopic visualization system power supplies have defective semiconductor components that may fail unexpectedly, which could result in an aborted procedure since it is a non recoverable failure. Manual removal of the bronchoscope when the system is not functioning can increase the chance of injury to the tissues of the lung as the scope is withdrawn including the possibility of pneumothorax.

On 10/28/24, recall notices were sent to customers who were told the firm would contact them to arrange inspection and replacement of the power supply system. Share this notification with any other healthcare professionals who may use the system. Complete and return the response form. Firm customer Service: customerservice@noahmed.com, 888-325-6624

• FDA enforcement recordOfficial FDA database entry for Z-0742-2025
• FDA 510(k) clearance · K223144The device's official FDA premarket clearance record
• FDA device classification · EOQOfficial FDA classification for this device type
• CFR regulation · 21 CFR 874.4680The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Noah MedicalSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.