{
  "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": 4
    }
  },
  "results": [
    {
      "cfres_id": "181017",
      "product_res_number": "Z-1709-2020",
      "event_date_initiated": "2019-12-03",
      "event_date_posted": "2020-04-24",
      "recall_status": "Open, Classified",
      "res_event_number": "85466",
      "product_code": "KGI",
      "k_numbers": [
        "K052581"
      ],
      "product_description": "Lunar iDXA bone densitometer",
      "code_info": "all affected systems",
      "firm_fei_number": "2126677",
      "recalling_firm": "GE Healthcare, LLC",
      "address_1": "3000 N Grandview Blvd",
      "city": "Waukesha",
      "state": "WI",
      "postal_code": "53188-1615",
      "additional_info_contact": "GE HEALTHCARE SERVICE\n800-437-1171",
      "reason_for_recall": "An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.",
      "root_cause_description": "Radiation Control for Health and Safety Act",
      "action": "GE Healthcare notified customers via an Electronic Product Radiation Warning Letter dated March 13, 2020.  The letter provided the following instructions.\n\n1)\tDiscontinue use of the start button on the control panel of the Lunar iDXA system to start a scan until a GE Representative can correct your system.\n2)\tDisable the control panel start button in the enCORE software by following the below steps:\n\"\tIn enCORE, select menu item Tools> User Options.\n\"\tSelect the measure tab.\n\"\tUncheck the option \"Allow Scanner Start Button to initiate a Measurement \"\n\"\tPress OK.\n3)\tStart the patient scan from the measure screen of the enCORE software.\n\nGE Healthcare will correct all affected Lunar iDXA systems by inspecting and replacing, if necessary, the iDXA control panel at no cost to the customer.\n\nFor questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.",
      "product_quantity": "123 in total",
      "distribution_pattern": "US Nationwide Distribution",
      "openfda": {
        "k_number": [
          "K961787",
          "K000162",
          "K901854",
          "K220822",
          "K001429",
          "K961007",
          "K983269",
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          "K890121",
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          "K981124",
          "K243218",
          "K945526",
          "K113356",
          "K973104",
          "K810140",
          "K133664",
          "K902959",
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          "K213760",
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          "K972053",
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          "K042480",
          "K905291",
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          "K901848",
          "K001756",
          "K992246",
          "K974437",
          "K913078",
          "K964263"
        ],
        "registration_number": [
          "3004977335",
          "3023003446",
          "3026043045",
          "2939827",
          "3044744649",
          "3008496839",
          "3008632256",
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          "3010687441",
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          "3039211310",
          "9616391",
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          "3008921184",
          "3031503890",
          "3003600763",
          "9616047",
          "3036666444",
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        ],
        "fei_number": [
          "3002175190",
          "3004977335",
          "1000124212",
          "3023003446",
          "3026043045",
          "3044744649",
          "3008496839",
          "3008632256",
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          "2183066",
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          "3019373577",
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          "3010687441",
          "3005496266",
          "3039211310",
          "3010208539",
          "3008921184",
          "1000646577",
          "3031503890",
          "3003600763",
          "3036666444",
          "3003377038"
        ],
        "device_name": "Densitometer, Bone",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.1170",
        "device_class": "2"
      }
    }
  ]
}