{
  "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": "202715",
      "product_res_number": "Z-2521-2023",
      "event_date_initiated": "2023-07-25",
      "event_date_posted": "2023-09-07",
      "recall_status": "Open, Classified",
      "res_event_number": "92854",
      "product_code": "FFX",
      "k_numbers": [
        "K012232"
      ],
      "product_description": "ZVU Functional GI Software, REF: ZVU-3",
      "code_info": "UDI-DI: 00816734022825, REV: 3.3.0, Software Version: 3.3.2109.6, Shipped between 5/4/2023 and 7/6/2023",
      "firm_fei_number": "2023374",
      "recalling_firm": "Diversatek Healthcare",
      "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": "303-470-7020",
      "reason_for_recall": "GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.",
      "root_cause_description": "Labeling Change Control",
      "action": "Starting on 7/25/23 recall notices were mailed and emailed to customers asking them to do the following:\n\n1) Discard affected product.\n2) Contact customer service 1-800-558-6408 for replacement.\n3) Complete and return the acknowledgement and receipt form.",
      "product_quantity": "20",
      "distribution_pattern": "worldwide - US Nationwide distribution in the states of NJ, MN, TN, WA, KY, OR, FL, GA, NY, TX, CO, KS and the countries of Japan, Saudi Arabia.",
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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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}