{
  "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": "123468",
      "product_res_number": "Z-0484-2014",
      "event_date_initiated": "2013-02-19",
      "event_date_posted": "2013-12-12",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-03-06",
      "res_event_number": "66790",
      "product_code": "FSY",
      "k_numbers": [
        "K011693"
      ],
      "product_description": "Helion S Exam Light or H300\r\n\r\nThe device is intended to locally illuminate an examination area of the patient's body with high intensity light in a clinic or doctor's practice.",
      "code_info": "Unknown",
      "firm_fei_number": "3003184737",
      "recalling_firm": "Trumpf Medical Systems, Inc.",
      "address_1": "415 Jessen Ln",
      "city": "Charleston",
      "state": "SC",
      "postal_code": "29492-7906",
      "additional_info_contact": "Lindsey Ronnenberg\n888-474-9359",
      "reason_for_recall": "Possible fatigue failure of the plastic joint may occur after an average use of seven years.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "TRUMPF sent an Urgent Recall Notice dated February 19, 2013, to all US affected customers. The letter identified the product the problem and the action needed to be taken by the customers. \r\n\r\nThe recall notice instructed customers to verify if they still have these light systems, and if they do have the light system verify if they have a metal or plastic ring at the joint of concern (per the manufacturer's Safety Notice). TRUMPF will directly work with affected customers to replace the affected arm system.\r\n\r\nFor further questions please call ( 888 ) 474-9359.",
      "product_quantity": "287",
      "distribution_pattern": "US Distribution including the states of AR, CA, CO, KS, MA, MI, MO, NJ, NY, NC, OH, OK, PA, SD, TX and WA.",
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        "device_name": "Light, Surgical, Ceiling Mounted",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4580",
        "device_class": "2"
      }
    }
  ]
}