{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "150595",
      "product_res_number": "Z-0369-2017",
      "event_date_initiated": "2016-10-03",
      "event_date_posted": "2016-11-05",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-06-07",
      "res_event_number": "75510",
      "product_code": "KGI",
      "k_numbers": [
        "K152299"
      ],
      "product_description": "TBS iNsight Version v.3.0.1\n\nProduct Usage:\nTBS iNsight is a medical device software that is installed on bone densitometers for analysis of bone microarchitecture and osteoporosis management.",
      "code_info": "Version v.3.0.1; Serial # 14295, 300409, 70580, 200042, 500581, 70103, 70174, 80936, 100202, 201120, 84584, 83769, 100112, 210020, 210440",
      "firm_fei_number": "3010208539",
      "recalling_firm": "Medimaps Group",
      "address_1": "18 fongit chemin des aulx",
      "city": "Plan-les-Ouates",
      "country": "Switzerland",
      "reason_for_recall": "The FRAX adjusted for TBS values are not correct when: The FRAX feature is activated in TBS iNsight; and TBS has been computed from a spine scan where some vertebrae were excluded.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Medimaps sent an Urgent Field Safety Notice letter dated October 3, 2016 to affected customers.  The letter identified the affected product, problem and actions to be taken.",
      "product_quantity": "15 units in US",
      "distribution_pattern": "Worldwide Distribution - US Nationwide - in the states of: IL, NC, CA, DE, NY, MD, WI, MN. And the following countries: France,Thailand, Croatia, Canada, Italy, Spain, Russian Federation, Ukraine, Lithuania, South Africa, Brazil, Lebanon, Saudi Arabia, Korea, China Portugalm Iraq, Syrian Arab Republic, Czech Republic, Australia, Belgium, Austria, Romania, New Zealand, Switzerland, Hong Kong, Sweden, Mexico, Islamic Republic of Iran, Serbia, Netherlands, Denmark, and UK.",
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        "device_name": "Densitometer, Bone",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.1170",
        "device_class": "2"
      }
    }
  ]
}