Medical Device Recall: 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 dia
Noah Medical · March 9, 2024
Reason for Recall
Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.
Product Description
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.
Distribution
U.S. Nationwide distribution in the states of CA, IN, MD, MO, OH, and PA.
States Affected
NATIONWIDE
Quantity Affected
17 wired controllers
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1734-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.