BEUDAMED
    FDA Enforcement Class II Terminated

    The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascularly through a catheter to occluded lesions in the peripheral arteries to cross them. The system is a self-contained unit that consists of a light source unit and a single use catheter. The light source contains a microprocessor with software to provide safety features and a user-friendly interface. The laser operates by producing a high current discharge within a chamber that is filled with rare gases and halogen. The discharge produces pulses of UV light, which is amplified by reflecting the energy within the resonating chamber many times. The output is directed to the desired target location by the catheter. A footswitch connected to the light source controls the laser action.

    Recall: Z-2218-2019 · Reported August 14, 2019

    Enforcement

    Recall Number
    Z-2218-2019
    Event ID
    83348
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ra Medical Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    August 14, 2019
    Initiation Date
    February 15, 2018
    Classification Date
    August 8, 2019
    Address
    2070 Las Palmas Dr, N/A, Carlsbad, CA, 92011-1518, United States

    Description

    The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascularly through a catheter to occluded lesions in the peripheral arteries to cross them. The system is a self-contained unit that consists of a light source unit and a single use catheter. The light source contains a microprocessor with software to provide safety features and a user-friendly interface. The laser operates by producing a high current discharge within a chamber that is filled with rare gases and halogen. The discharge produces pulses of UV light, which is amplified by reflecting the energy within the resonating chamber many times. The output is directed to the desired target location by the catheter. A footswitch connected to the light source controls the laser action.

    Reason

    Lasers/Catheters did not calibrate during set-up prior to use.

    Code Info

    Serial Numbers: 0016, 0039, 0044, 0048

    Distribution

    U.S: CA, PA

    Quantity

    4