FDA recall Z-0598-2026

Noah Medical Corporation · Class II · device

Product

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.

Reason for recall

Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.

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

Key facts

Status
Ongoing
Initiation date
2025-09-12
Report date
2025-12-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Jose, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0598-2026