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Noah Medical recalls Galaxy System (GAL-001)
Recalled December 25, 2024 · FDA recall Z-0693-2025 · Noah Medical
Hazard
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. · FDA Class II
Units
26
Sold at
US: CA, MA, PA, NJ, ID, CT, MO, NC, MD, IL, TN, VA, OH, IN, WV, NY
Description
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.
Product
Galaxy System (GAL-001)
Manufacturer(s)
Noah Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →