FDA-Device2024-05-08Class II
Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
Noah Medical
Hazard
Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.
Sold states
U.S. Nationwide distribution in the states of CA, IN, MD, MO, OH, and PA.
Affected count
17 wired controllers
Manufactured in
1501 Industrial Rd, San Carlos, CA, United States
Products
Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1734-2024Don't want to check this manually?
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