Galaxy Bronchoscopic System (Noah Medical) – power supply failure risk (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
Brand
Noah Medical
Lot Codes / Batch Numbers
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
Products Sold
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,
Noah Medical is recalling Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient ai due to Bronchoscopic visualization system power supplies have defective semiconductor components that may fail unexpectedly, which could result in an aborted. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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when the system is not functioning can increase the chance of injury to the tissues of the lung as the scope is withdrawn including the possibility of pneumothorax.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CT, ID, IN, MD, MA, MO, NJ, NY, NC, OH, PA, SC, TN, WV
Page updated: Jan 10, 2026