{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "174863",
      "product_res_number": "Z-2218-2019",
      "event_date_initiated": "2018-02-15",
      "event_date_created": "2019-08-08",
      "recall_status": "Terminated",
      "res_event_number": "83348",
      "product_code": "PDU",
      "k_numbers": [
        "K170349"
      ],
      "product_description": "The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascularly through a catheter to occluded lesions in the peripheral arteries to cross them.\nThe system is a self-contained unit that consists of a light source unit and a single use catheter. The light source contains a microprocessor with software to provide safety features and a user-friendly interface.\nThe laser operates by producing a high current discharge within a chamber that is filled with rare gases and halogen. The discharge produces pulses of UV light, which is amplified by reflecting the energy within the resonating chamber many times. The output is directed to the desired target location by the catheter. A footswitch connected to the light source controls the laser action.",
      "code_info": "Serial Numbers: 0016, 0039, 0044, 0048",
      "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": "Dean Irwin\n877-635-1800",
      "reason_for_recall": "Lasers/Catheters did not calibrate during set-up prior to use.",
      "root_cause_description": "Other",
      "action": "On 02/15/18, service technicians started visiting customer facilities to service affected lasers.",
      "product_quantity": "4",
      "distribution_pattern": "U.S: CA, PA",
      "openfda": {
        "k_number": [
          "K052514",
          "K060012",
          "K203363",
          "K221541",
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          "K140288",
          "K251158",
          "K140438",
          "K101615",
          "K220544",
          "K031005",
          "K122380",
          "K131914"
        ],
        "registration_number": [
          "3008363989",
          "3020968442",
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          "3009128730",
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          "2011171",
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        ],
        "fei_number": [
          "3008363989",
          "3020968442",
          "1450662",
          "3009128730",
          "1000306216",
          "3007284006",
          "1643817",
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          "3003528016",
          "1018233",
          "3005580113",
          "2939520",
          "2011171",
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        ],
        "device_name": "Catheter For Crossing Total Occlusions",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1250",
        "device_class": "2"
      }
    }
  ]
}