Noah Medical recalls Galaxy System (GAL-001)

Recall date

October 25, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0693-2025

FDA classification

Class II

Brand / firm

Noah Medical

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Galaxy System (GAL-001)