BEUDAMED
    FDA Enforcement Class II Terminated

    DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular disease.

    Recall: Z-0050-2021 · Reported October 14, 2020

    Enforcement

    Recall Number
    Z-0050-2021
    Event ID
    86217
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ra Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 14, 2020
    Initiation Date
    July 24, 2020
    Classification Date
    October 2, 2020
    Termination Date
    August 9, 2023
    Address
    2070 Las Palmas Dr, N/A, Carlsbad, CA, 92011-1518, United States

    Description

    DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular disease.

    Reason

    Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury.

    Code Info

    Model Number DABRA Excimer Laser RA-308; Serial Numbers: RA00027, RA00039, RA00046, RA00049, RA00050, RA00054, RA00055, RA00056, RA00057, RA00058, RA00063, RA00064, RA00065, RA00067, RA00069, RA00070, RA00073, RA00074, RA00081, RA00082, RA00083, RA00084, RA00085, RA00086, RA00088, RA00089, RA00097, RA00098, RA00103, RA00114, RA00115, RA00117, RA00118, RA00120, RA00121, RA00124, RA00125, RA00127, RA00135, RA00136, RA00137, RA00138, RA00143, RA00147, RA00148, RA00153, RA00154, RA00160, RA00164, RA00165, RA00167, RA00170, RA00175, and RA00177.

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, FL, ID, IL, IN, KS, KY, LA, MA, MD, MI, NC, NV, NY, OR, OK, PA, TX, WA and the country of Japan.

    Quantity

    54 units