Medical Device Recall: Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
Noah Medical · October 28, 2024
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when the system is not functioning can increase the chance of injury to the tissues of the lung as the scope is withdrawn including the possibility of pneumothorax.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
States Affected
CA, CT, ID, IN, MA, MD, MO, NC, NJ, NY, OH, PA, SC, TN, WV
Quantity Affected
18
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0742-2025
Status: ongoing
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