Noah Medical recalled 47 units of its Galaxy System on September 12, 2025. Users could not access crucial instructions due to password protection on the user manual. This recall affects distribution in 15 U.S. states and two countries.
Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Noah Medical Corporation or your healthcare provider for instructions. Notification method: N/A
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The Galaxy System, model GAL-001, is intended for bronchoscopic visualization. It was distributed to New York, Massachusetts, West Virginia, and other states. The recall involves 47 units.
Users cannot access the Instructions for Use/User Manual due to password protection. This lack of access poses a high risk to patient safety during diagnostic and therapeutic procedures.
No incidents have been reported related to this issue. However, the inability to access operational instructions creates a significant safety concern.
Stop using the Galaxy System immediately. Contact Noah Medical Corporation or your healthcare provider for further instructions.
For more information, visit the recall page at the FDA website or contact Noah Medical Corporation directly.
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