Noah Medical FDA Recalls

4 recalls on file across devices, 0 of them Class I and 4 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostiClass IIOct 28, 2024Bronchoscopic visualization system power supplies have defec	Bronchoscopic visualization system power supplies have defective semiconductor components that may fail unexpe	Class IIDevices	Oct 28, 2024
Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy SClass IIOct 25, 2024Not all biopsy tools meant to fit bronchoscope channel (2.1m	Not all biopsy tools meant to fit bronchoscope channel (2.1mm inner diameter/length greater or equal to 1100mm	Class IIDevices	Oct 25, 2024
Galaxy System (GAL-001)Class IIOct 25, 2024Bronchoscopic system uninterruptable power may have defectiv	Bronchoscopic system uninterruptable power may have defective component, may cause power supply short circuit/	Class IIDevices	Oct 25, 2024
Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intendedClass IIMar 9, 2024Due to a misaligned calibration of the wired controller that	Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.	Class IIDevices	Mar 9, 2024