BEUDAMED
    FDA Recall Open, Classified

    (1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802, Laser System; and (3) Lumenis Pulse 120H, REF GA-0008700, Laser System.

    Recall: Z-1290-2025 · Initiated January 23, 2025

    Recall

    Recall Number
    Z-1290-2025
    Event Number
    96197
    Firm
    LUMENIS, LTD. Yokneam Ind. Park 6, Ha-Kidma Yokne'Am Ilit Israel
    FEI Number
    3004135191
    Product Code
    GEX
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    January 23, 2025
    Posted
    March 5, 2025

    Description

    (1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802, Laser System; and (3) Lumenis Pulse 120H, REF GA-0008700, Laser System.

    Reason

    The initial current in certain chargers may lead to overheating and damage to the power resistors on the Alternating Current (AC) controller during the power-on sequence of the laser system, resulting in the laser system to not power on.

    Action

    The recall was initiated via letter dated and issued on 1/23/2025 via FEDEX in the U.S. and via mail, courier, or hand delivery OUS. The letter explained the issue and the scenarios as to when the laser system would not power on. The consignee is instructed to immediately discontinue use and segregate the device, post this information in a visible location near the affected product to ensure the information is readily accessible to all handlers and users of the device, share the notice with any health care professional within your organization and with any organization where the affected product may have been transferred, and if the device has been further distributed, notify the customer to ensure this product removal is carried out to the end-user level. A Reply Verification Tracking Form was enclosed for completion and return. Once the firm receives the completed form, the consignee will be contacted within 2 business days and provided an RGA number for product return.

    Distribution

    Distribution was made to PA. There was no government/military distribution. Foreign distribution was made to Mexico and Spain.

    Quantity

    3 devices