BEUDAMED
    FDA Recall Terminated

    DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channel in occlusive peripheral vascular disease. Indications: For crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease.

    Recall: Z-0569-2021 · Initiated October 16, 2020

    Recall

    Recall Number
    Z-0569-2021
    Event Number
    86692
    Firm
    Ra Medical Systems, Inc.
    FEI Number
    3004217728
    Product Code
    PDU
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 16, 2020
    Terminated
    January 11, 2023
    Address
    2070 Las Palmas Dr, Carlsbad, CA, 92011-1518

    Description

    DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channel in occlusive peripheral vascular disease. Indications: For crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease.

    Reason

    Due to footswitch not meeting required specification for protection from ingress of solids or liquids. If spilling of liquids near or on the footswitch, it may fail in the 'on' position and allow the laser to continue to lase.

    Action

    On 10/29/2020, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Notification via certified mail informing them of the potential for the footswitch to fail to operate properly if liquid is spilled near or on the footswitch. On 11/16/2020, the firm sent out an updated customer notification. The firm is instructing customers to discontinue using the footswitch if liquids have been spilled on or splashed on the floor near or on the footswitch. The Recalling Firm will ship a replacement footswitch and will provide shipping materials for users to return the old footswitch. Instructions will be provided on how to install the new footswitch and return the old footswitch. Customers are asked to fill out and return the Acknowledgement and Receipt Form via FAX to 760-867-2706 or email at [email protected]. For any questions, contact the Recalling Firm at: 1-877-635-1800 Monday thru Friday 8:00 a.m. to 5:00 p.m. PST

    Distribution

    US Distribution to states of: AL, AZ, CA, FL, IL, IN, KY, LA, MD, NC, NV, NY, OK, OR, TX, and WA; and to OUS country: Japan.

    Quantity

    36 devices