Class II

Medical Device Recall: Galaxy System (GAL-001)

Noah Medical · October 25, 2024

Reason for Recall

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.

Distribution

US: CA, MA, PA, NJ, ID, CT, MO, NC, MD, IL, TN, VA, OH, IN, WV, NY

States Affected

CA, CT, ID, IL, IN, MA, MD, MO, NC, NJ, NY, OH, PA, TN, VA, WV

Quantity Affected

26

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0693-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.