Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
This recall is currently active, issued December 20, 2024. It was issued by Noah Medical.
- Company
- Noah Medical
- Recall Initiated
- October 28, 2024
- Posted
- December 20, 2024
- Recall Number
- Z-0742-2025
- Quantity
- 18
- Firm Location
- San Carlos, CA
- Official Source
- View on FDA website ↗
Reason for Recall
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when the system is not functioning can increase the chance of injury to the tissues of the lung as the scope is withdrawn including the possibility of pneumothorax.
Distribution
US: SC, OH, PA, TN, MO, IN, CA, WV, NY, MD, MA, NJ, ID, CT, NC
Lot / Code Info
UDI-DI: 00850048825048. Serial Numbers: CRB-1502, CRB-1503, CRB-1506, CRB-1508, CRB-1516, CRB-1517, CRB-1519, CRB-1520, CRB-1521, CRB-1522, CRB-1523, CRB-1524, CRB-1525, CRB-1527, CRB-1528, CRB-1529, CRB-1530, CRB-1532,
Root Cause
Component change control
Action Taken
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