FDA-Device2024-12-25Class II
Galaxy System (GAL-001)
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.
Sold states
US: CA, MA, PA, NJ, ID, CT, MO, NC, MD, IL, TN, VA, OH, IN, WV, NY
Affected count
26
Manufactured in
1501 Industrial Rd, San Carlos, CA, United States
Products
Galaxy System (GAL-001)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0693-2025Don't want to check this manually?
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