Recall Z-0742-2025 ยท EOQ Bronchoscope (Flexible Or Rigid)
Noah Medical
Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
| Date | Dec 20, 2024 (initiated Oct 28, 2024) |
| Status | Open, Classified |
| Reason | Bronchoscopic visualization system power supplies have defective semiconductor components that may fail unexpectedly, which could result in an aborted procedure since it is a non recoverable failure. Manual removal of the bronchoscope when the system is not functioning can increase the chance of injury to the tissues of the lung as the scope is withdrawn including the possibility of pneumothorax. |
| Root cause | Component change control |
| Action | On 10/28/24, recall notices were sent to customers who were told the firm would contact them to arrange inspection and replacement of the power supply system. Share this notification with any other healthcare professionals who may use the system. Complete and return the response form. Firm customer Service: customerservice@noahmed.com, 888-325-6624 |
| Quantity | 18 |
| Distribution | US: SC, OH, PA, TN, MO, IN, CA, WV, NY, MD, MA, NJ, ID, CT, NC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223144 | Galaxy System Noah Medical Corp., Mar 1, 2023 |