Noah Medical: Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

Hazard

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when the system is not functioning can increase the chance of injury to the tissues of the lung as the scope is withdrawn including the possibility of pneumothorax.

Details from the source

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when the system is not functioning can increase the chance of injury to the tissues of the lung as the scope is withdrawn including the possibility of pneumothorax.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 Quantity: 18 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,

UPC codes

00850048825048

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.