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.
FDA Recall Z-0598-2026 · Posted 2025-11-26
Advertisement
Recalling FirmNoah Medical Corporation
Recall StatusOpen, Classified
Product CodeEOQ
Date Initiated2025-09-12
Product Quantity47
Reason for Recall
Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.
Firm Action
On 09/12/2025, the firm sent via FedEx an "Urgent: MEDICAL DEVICE RECALL" Letter to customers. The letter described the product, risk to health and action to be taken.
Customers were notified that the password has been removed and they are instructed to:
Log in and access the applicable IFU and all addendums. Noah Medical recommends that customers download the IFU and addendums for ease of reference.
For questions contact:
Noah Medical Customer Service
email: [email protected] Noah hotline: 888-325-NOAH (1-888-325-6624)
Root Cause
Under Investigation by firm
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement