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.
Recall
- Recall Number
- Z-0598-2026
- Event Number
- 97656
- Firm
- Noah Medical Corporation
- FEI Number
- 3021325287
- Product Code
- EOQ
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- September 12, 2025
- Posted
- November 26, 2025
- Address
- 2075 Zanker Rd, San Jose, CA, 95131-2107
Description
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.
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)
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
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