BEUDAMED
    FDA Enforcement Class II Terminated

    DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviolet light source and delivery system, collectively the DABRA Laser System". The system is designed to deliver the energy to the surgical site to ablate unwanted material. The optical conduit is used in conjunction with existing endovascular accessories and tools to complete a surgical procedure. The software is programmed onto an EEPROM chip, which is a component of the DABRA Excimer Laser RA-308 system. Catheter for crossing total occlusions in vascular system.

    Recall: Z-2497-2020 · Reported July 15, 2020

    Enforcement

    Recall Number
    Z-2497-2020
    Event ID
    85790
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ra Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 15, 2020
    Initiation Date
    January 23, 2020
    Classification Date
    July 4, 2020
    Termination Date
    November 1, 2021
    Address
    2070 Las Palmas Dr, Carlsbad, CA, 92011-1518, United States

    Description

    DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviolet light source and delivery system, collectively the DABRA Laser System". The system is designed to deliver the energy to the surgical site to ablate unwanted material. The optical conduit is used in conjunction with existing endovascular accessories and tools to complete a surgical procedure. The software is programmed onto an EEPROM chip, which is a component of the DABRA Excimer Laser RA-308 system. Catheter for crossing total occlusions in vascular system.

    Reason

    A software issue was identified which could result in user or patient injury, or may adversely impact laser performance. It is possible that an unintended release of laser light (radiation) may occur, injuring the user or patient.

    Code Info

    Serial Number(s): RA00027 through RA00176;all DABRA excimer laser RA-308 product is impacted.

    Distribution

    US: AL, AZ, CA, FL, GA, ID, IL, IN, KS, KY, LA, MI, MD, NC, NV, NY, OK, OR, PA, TN,TX, WI. OUS: Italy and Japan.

    Quantity

    79 units