{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "184324",
      "product_res_number": "Z-0569-2021",
      "event_date_initiated": "2020-10-16",
      "event_date_created": "2020-12-14",
      "recall_status": "Terminated",
      "event_date_terminated": "2023-01-11",
      "res_event_number": "86692",
      "product_code": "PDU",
      "k_numbers": [
        "K170349"
      ],
      "product_description": "DABRA Laser (RA-308 Excimer Laser)\n\nIntended 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.",
      "code_info": "Model Number RA-308 Product/Catalog Number: 1200-0001-01 Serial Numbers: RA00027, RA00046, RA00049, RA00050, RA00054, RA00056, RA00057, RA00058, RA00064, RA00069, RA00073, RA00081, RA00083, RA00084, RA00085, RA00089, RA00097, RA00098, RA00114, RA00115, RA00120, RA00121, RA00125, RA00127, RA00135, RA00138, 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 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.",
      "root_cause_description": "Device Design",
      "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.\n\nCustomers are asked to fill out and return the Acknowledgement and Receipt Form via FAX to 760-867-2706 or email at fieldcorrectiveaction@ramed.com.\n\nFor any questions, contact the Recalling Firm at: 1-877-635-1800 Monday thru Friday 8:00 a.m. to 5:00 p.m. PST",
      "product_quantity": "36 devices",
      "distribution_pattern": "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.",
      "openfda": {
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          "K210839",
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          "K140438",
          "K212468",
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          "K040067",
          "K033535",
          "K072155",
          "K252315",
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          "K232562",
          "K091119",
          "K120533",
          "K210664",
          "K083814",
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          "K113838",
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          "K122380",
          "K120273",
          "K140288",
          "K123532",
          "K230594",
          "K221163",
          "K150836",
          "K251158",
          "K201330",
          "K060012",
          "K031842",
          "K150187",
          "K131914",
          "K220544",
          "K211802",
          "K162418",
          "K230159",
          "K192211",
          "K251376",
          "K023114",
          "K101599",
          "K052296",
          "K221541",
          "K101777",
          "K081804",
          "K161208",
          "K112308",
          "K071227",
          "K183357"
        ],
        "registration_number": [
          "3023527320",
          "3008789872",
          "2030598",
          "2011171",
          "3008729892",
          "1018233",
          "3009018440",
          "3009561706",
          "3003637635",
          "3020968442",
          "1313046",
          "1643817",
          "3000126629",
          "3005580113",
          "3006082230",
          "1016427",
          "9616099",
          "3007284006",
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          "3002807314",
          "3027058844",
          "1724474",
          "1450662",
          "2126666",
          "2939520",
          "3013757884",
          "2528981",
          "3009882464",
          "1820334",
          "3009039068",
          "2183870"
        ],
        "fei_number": [
          "3023527320",
          "3008789872",
          "1000138054",
          "2011171",
          "1018233",
          "3009018440",
          "3009561706",
          "3003637635",
          "3020968442",
          "1313046",
          "1643817",
          "3000126629",
          "3003528016",
          "3005580113",
          "3006082230",
          "1016427",
          "3007284006",
          "1721676",
          "3003094851",
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          "1000306216",
          "3008998256",
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          "3027058844",
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          "2939520",
          "3013757884",
          "2528981",
          "3002807555",
          "3009882464",
          "1820334",
          "3009039068",
          "2183870"
        ],
        "device_name": "Catheter For Crossing Total Occlusions",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1250",
        "device_class": "2"
      }
    }
  ]
}