Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
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...
Class IIReported ongoing
Distribution: US: SC, OH, PA, TN, MO, IN, CA, WV, NY, MD, MA, NJ, ID, CT, NC