BEUDAMED
    FDA Recall Open, Classified

    Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

    Recall: Z-0742-2025 · Initiated October 28, 2024

    Recall

    Recall Number
    Z-0742-2025
    Event Number
    95585
    Firm
    Noah Medical
    FEI Number
    3021325287
    Product Code
    EOQ
    Status
    Open, Classified
    Root Cause
    Component change control
    Initiated
    October 28, 2024
    Posted
    December 20, 2024
    Address
    1501 Industrial Rd, San Carlos, CA, 94070-4111

    Description

    Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

    Reason

    Bronchoscopic visualization system power supplies have defective semiconductor components that may fail unexpectedly, which could result in an aborted procedure since it is a non recoverable failure. Manual removal of the bronchoscope when the system is not functioning can increase the chance of injury to the tissues of the lung as the scope is withdrawn including the possibility of pneumothorax.

    Action

    On 10/28/24, recall notices were sent to customers who were told the firm would contact them to arrange inspection and replacement of the power supply system. Share this notification with any other healthcare professionals who may use the system. Complete and return the response form. Firm customer Service: [email protected], 888-325-6624

    Distribution

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

    Quantity

    18