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

Recall date

October 28, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0742-2025

FDA classification

Class II

Brand / firm

Noah Medical

Sold / distributed

US: SC, OH, PA, TN, MO, IN, CA, WV, NY, MD, MA, NJ, ID, CT, NC

Why it was recalled

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when the system is not functioning can increase the chance of injury to the tissues of the lung as the scope is withdrawn including the possibility of pneumothorax.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.