Recall Z-0693-2025 ยท EOQ Bronchoscope (Flexible Or Rigid)
Noah Medical
Galaxy System (GAL-001)
| Date | Dec 18, 2024 (initiated Oct 25, 2024) |
| Status | Open, Classified |
| Reason | Bronchoscopic system uninterruptable power may have defective component, may cause power supply short circuit/trip protective circuit breakers causing sudden, unrecoverable power loss, which could occur while system is on mains or internal battery power; if during procedure, could cause interrupted/aborted procedure, may necessitate manual removal, which could lead to lung injury/pneumothorax. |
| Root cause | Device Design |
| Action | On 10/25/24, the firm started hand delivering correction notices to customers informing them of the following: If your device is affected the firm will contact you to inspect and if necessary to replace the power supply. Firm contact: customerservice@noahmed.com, 1-888-325-6624 |
| Quantity | 26 |
| Distribution | US: CA, MA, PA, NJ, ID, CT, MO, NC, MD, IL, TN, VA, OH, IN, WV, NY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223144 | Galaxy System Noah Medical Corp., Mar 1, 2023 |