Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.
U.S. Nationwide distribution in the states of CA, IN, MD, MO, OH, and PA.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1734-2024