{
  "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": "2026-10-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "86301",
      "product_res_number": "Z-1487-2012",
      "event_date_initiated": "2009-02-23",
      "event_date_posted": "2012-05-07",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-05-07",
      "res_event_number": "53340",
      "product_code": "FFX",
      "k_numbers": [
        "K012232"
      ],
      "product_description": "Insight rev H software. \n\nThe InSIGHT Gastrointestinal Motility System is intended for use by gastroenterologists, surgeons, and medically trained personnel for esophageal, biliary, and anorectal studies as an aid in documenting and diagnosing digestive motility disorders.",
      "code_info": "S98-1925-2H; S98-1925-4H All lots and shipments of the software.",
      "firm_fei_number": "2023374",
      "recalling_firm": "Sandhill Scientific, Inc",
      "address_1": "9150 Commerce Center Cir Ste 500 9150 Commerce Center Cir",
      "address_2": "Ste 500",
      "city": "Highlands Ranch",
      "state": "CO",
      "postal_code": "80129-1563",
      "additional_info_contact": "Guy Harris\n800-468-4556 Ext. 1021",
      "reason_for_recall": "Software error may produce incorrect esophageal contraction readings.",
      "root_cause_description": "Software change control",
      "action": "Sandhill Scientific sent a Urgent Product Recall letter dated February 23, 2009, to all affected customers.  The letter identified the product the problem and the action needed to be taken by the customer. \n\nThe customers were informed All Suite revision H, BioVIEW Analysis Software rev 5.5.1 are affected. Replacement of the Suite revision H, BioVIEW Analysis Software rev 5.5.1,  will be provided at no cost to you.  Sandhill Scientific will pay for shipping/handling charges associated with replacement of this software.\n\nWe anticipate that by the first week of March, we will be able to provide you with the Software that resolves this problem.\n\nFor further questions please call toll free 800-468-4556.",
      "product_quantity": "60 programs",
      "distribution_pattern": "Worldwide Distribution--USA (nationwide) including the states of  CA, CO, CT, FL, IA, IL, MA, MD, MI, MN, NC, ND, NE, NM, NY, OH, OR, PA, SC, SD, TX, UT, VA and WA and the countries of Belgium, Canada, Malaysia, Mexico, New Zealand, South-Korea, Switzerland and United Kingdom.",
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        ],
        "device_name": "System, Gastrointestinal Motility (Electrical)",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1725",
        "device_class": "2",
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