Recall Z-0598-2026 ยท EOQ Bronchoscope (Flexible Or Rigid)
Noah Medical Corporation
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.
| Date | Nov 26, 2025 (initiated Sep 12, 2025) |
| Status | Open, Classified |
| Reason | Due to Users not having access to the Instructions for Use/User Manual due to it being password protected. |
| Root cause | Under Investigation by 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: customerservice@noahmed.com Noah hotline: 888-325-NOAH (1-888-325-6624) |
| Quantity | 47 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223144 | Galaxy System Noah Medical Corp., Mar 1, 2023 |