{
  "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": "174540",
      "product_res_number": "Z-0163-2020",
      "event_date_initiated": "2019-06-26",
      "event_date_created": "2019-10-18",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-10-29",
      "res_event_number": "83278",
      "product_code": "HBL",
      "k_numbers": [
        "K113748"
      ],
      "product_description": "IMRIS MR/X-ray head fixation device, Model HFD200",
      "code_info": "HFD Serial Number\t Drive Knob Serial Number  10002481\t\t10003305 10002351\t\t10005723 10004247\t\t10002448",
      "firm_fei_number": "3010326005",
      "recalling_firm": "Deerfield Imaging, Inc.",
      "address_1": "5101 Shady Oak Rd S",
      "city": "Minnetonka",
      "state": "MN",
      "postal_code": "55343-4100",
      "additional_info_contact": "customer support\n866-475-0525",
      "reason_for_recall": "Breaking of the HFD200 Drive Knob force indicator due to over-torqueing of the drive knob beyond the maximum allowable pinning force specification may result in the clinical staff unknowingly pinning the patient's skull with insufficient force; the clinical staff unknowingly pinning the patient's skull with excessive force; or the clinical staff identifying the issue and not being able to continue with the procedure.",
      "root_cause_description": "Device Design",
      "action": "The firm disseminated a field safety notice on 06/26/2019 by letter.  The notice explained the problem and requested that the consignee inspect the skull clamp prior to use and be aware that overtightening of the drive knob may result in failure.  The drive knobs will be replaced with an updated design when available.",
      "product_quantity": "3 units",
      "distribution_pattern": "TN, NH, FL",
      "openfda": {
        "k_number": [
          "K063494",
          "K193438",
          "K090695",
          "K021604",
          "K090506",
          "K103493",
          "K240319",
          "K032331",
          "K072208",
          "K932807",
          "K141950",
          "K913170",
          "K001808",
          "K031885",
          "K142238",
          "K912005",
          "K083803",
          "K050319",
          "K955012",
          "K901393",
          "K893911",
          "K941558",
          "K932860",
          "K002990",
          "K113748",
          "K241883",
          "K073163",
          "K163322",
          "K874298",
          "K821772",
          "K002276",
          "K071458",
          "K203505",
          "K051440",
          "K934289",
          "K120633",
          "K250423",
          "K191701",
          "K053045",
          "K911723",
          "K953124",
          "K081401",
          "K091439",
          "K191740",
          "K923789",
          "K911772",
          "K191979",
          "K122225",
          "K912011",
          "K130389"
        ],
        "device_name": "Holder, Head, Neurosurgical (Skull Clamp)",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.4460",
        "device_class": "2",
        "registration_number": [
          "3004929307",
          "2032092",
          "3011547624",
          "3011689956",
          "8043933",
          "3003418325",
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        ],
        "fei_number": [
          "3004929307",
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          "3011689956",
          "3003418325",
          "1000127185",
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      }
    }
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}