Recall Z-0598-2026— Noah Medical Corporation
Class II · Ongoing
Class II FDA medical device recall by Noah Medical Corporation, initiated 2025-09-12. It names one FDA 510(k) clearance: K223144. 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: Due to Users not having access to the Instructions for Use/User Manual due to it being password protected..
- Recalling firm
- Noah Medical Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-09-12
- Firm location
- San Jose, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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.
Reason for recall
Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.
Data sourced from openFDA. This site is unofficial and independent of the FDA.