BEUDAMED
    FDA Enforcement Class II Ongoing

    Galaxy System (GAL-001)

    Recall: Z-0693-2025 · Reported December 25, 2024

    Enforcement

    Recall Number
    Z-0693-2025
    Event ID
    95712
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Noah Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 25, 2024
    Initiation Date
    October 25, 2024
    Classification Date
    December 18, 2024
    Address
    1501 Industrial Rd, San Carlos, CA, 94070-4111, United States

    Description

    Galaxy System (GAL-001)

    Reason

    Bronchoscopic system uninterruptable power may have defective component, may cause power supply short circuit/trip protective circuit breakers causing sudden, unrecoverable power loss, which could occur while system is on mains or internal battery power; if during procedure, could cause interrupted/aborted procedure, may necessitate manual removal, which could lead to lung injury/pneumothorax.

    Code Info

    UDI-DI: 00850048825048. Serial Numbers: CRB-1502, CRB-1503, CRB-1508, CRB-1513, CRB-1514, CRB-1515, CRB-1516, CRB-1518, CRB-1519, CRB-1520, CRB-1521, CRB-1522, CRB-1523, CRB-1524, CRB-1525, CRB-1528, CRB-1530, CRB-1532, CRB-1534, CRB-1535, CRB-1537, CRB-1538, CRB-1540, CRB-1541, CRB-1543, CRB-1554

    Distribution

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

    Quantity

    26