BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-0742-2025 · Reported January 1, 2025

    Enforcement

    Recall Number
    Z-0742-2025
    Event ID
    95585
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Noah Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 1, 2025
    Initiation Date
    October 28, 2024
    Classification Date
    December 20, 2024
    Address
    1501 Industrial Rd, San Carlos, CA, 94070-4111, United States

    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when the system is not functioning can increase the chance of injury to the tissues of the lung as the scope is withdrawn including the possibility of pneumothorax.

    Code Info

    UDI-DI: 00850048825048. Serial Numbers: CRB-1502, CRB-1503, CRB-1506, CRB-1508, CRB-1516, CRB-1517, CRB-1519, CRB-1520, CRB-1521, CRB-1522, CRB-1523, CRB-1524, CRB-1525, CRB-1527, CRB-1528, CRB-1529, CRB-1530, CRB-1532,

    Distribution

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

    Quantity

    18