BEUDAMED
    FDA Recall 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 · Initiated July 24, 2020

    Recall

    Recall Number
    Z-0050-2021
    Event Number
    86217
    Firm
    Ra Medical Systems, Inc.
    FEI Number
    3004217728
    Product Code
    PDU
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 24, 2020
    Terminated
    August 9, 2023
    Address
    2070 Las Palmas Dr, Carlsbad, CA, 92011-1518

    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.

    Action

    On August 10, 2020, the firm sent an "Urgent Medical Correction" letter to customers, informing them of the incorrect laser wheel size, which upon moving or adjusting the laser with the wheels in locked position may fall over. If this were to happen during a medical procedure, user or patient injury may occur.

    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