BEUDAMED
    FDA Recall Open, Classified

    Galaxy System (GAL-001)

    Recall: Z-0693-2025 · Initiated October 25, 2024

    Recall

    Recall Number
    Z-0693-2025
    Event Number
    95712
    Firm
    Noah Medical
    FEI Number
    3021325287
    Product Code
    EOQ
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    October 25, 2024
    Posted
    December 18, 2024
    Address
    1501 Industrial Rd, San Carlos, CA, 94070-4111

    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.

    Action

    On 10/25/24, the firm started hand delivering correction notices to customers informing them of the following: If your device is affected the firm will contact you to inspect and if necessary to replace the power supply. Firm contact: [email protected], 1-888-325-6624

    Distribution

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

    Quantity

    26