Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy SystemTM and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedure.
Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.
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Recall Number
Z-0598-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-09-12
Reported
2025-12-03
Distribution
US distribution to states of: NY, MA, WV, WY, TN, OH, NJ, MN, CA, MO, ID, IN, PA, MD, VA, WI, CO, SC, IL, NC and OUS (Foreign) to countries of: Hong Kong and Australia