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Noah Medical recalls Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnosti
Recalled January 1, 2025 · FDA recall Z-0742-2025 · Noah Medical
Hazard
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when the system is not functioning can increase the chance of injury to the tissues of the lung as the scope is withdrawn including the possibility of pneumothorax. · FDA Class II
Units
18
Sold at
US: SC, OH, PA, TN, MO, IN, CA, WV, NY, MD, MA, NJ, ID, CT, NC
Description
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when the system is not functioning can increase the chance of injury to the tissues of the lung as the scope is withdrawn including the possibility of pneumothorax.
Product
Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
Manufacturer(s)
Noah Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →