{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "183111",
      "product_res_number": "Z-0050-2021",
      "event_date_initiated": "2020-07-24",
      "event_date_created": "2020-10-02",
      "recall_status": "Terminated",
      "event_date_terminated": "2023-08-09",
      "res_event_number": "86217",
      "product_code": "PDU",
      "k_numbers": [
        "K170349"
      ],
      "product_description": "DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular disease.",
      "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.",
      "firm_fei_number": "3004217728",
      "recalling_firm": "Ra Medical Systems, Inc.",
      "address_1": "2070 Las Palmas Dr",
      "city": "Carlsbad",
      "state": "CA",
      "postal_code": "92011-1518",
      "additional_info_contact": "Will McGuire\n760-804-1648",
      "reason_for_recall": "Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury.",
      "root_cause_description": "Device Design",
      "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.",
      "product_quantity": "54 units",
      "distribution_pattern": "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.",
      "openfda": {
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          "K113838",
          "K083814",
          "K230594",
          "K183357",
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        ],
        "registration_number": [
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        "fei_number": [
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        ],
        "device_name": "Catheter For Crossing Total Occlusions",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1250",
        "device_class": "2"
      }
    }
  ]
}