BEUDAMED
    FDA Enforcement Class II Ongoing

    (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 · Reported March 12, 2025

    Enforcement

    Recall Number
    Z-1290-2025
    Event ID
    96197
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    LUMENIS, LTD.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 12, 2025
    Initiation Date
    January 23, 2025
    Classification Date
    March 5, 2025
    Address
    Yokneam Ind. Park, 6, Ha-Kidma, Yokne'Am Ilit, N/A, Israel

    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.

    Code Info

    Software version 2.4.1.0. (1) REF GA-2009996 - Serial number 1791, UDI-DI 07290109145518; (2) REF GA-0006802 - Serial number 1803, UDI-DI 07290109145525; and (3) REF-GA0008700 - Serial number 1818, UDI-DI 07290109145464.

    Distribution

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

    Quantity

    3 devices