{
  "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,
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  "results": [
    {
      "cfres_id": "121143",
      "product_res_number": "Z-0426-2014",
      "event_date_initiated": "2013-03-12",
      "event_date_posted": "2013-11-27",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-06-26",
      "res_event_number": "65985",
      "product_code": "KOG",
      "k_numbers": [
        "K122172",
        "K983017"
      ],
      "product_description": "Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.",
      "code_info": "Multiple serial numbers",
      "firm_fei_number": "2523209",
      "recalling_firm": "Custom Ultrasonics, Inc.",
      "address_1": "144 Railroad Dr",
      "city": "Ivyland",
      "state": "PA",
      "postal_code": "18974-1449",
      "additional_info_contact": "Customer Support\n215-364-1477",
      "reason_for_recall": "Certain System 83 Plus 2 and System 83 Plus 9 units running the Windows 7 operating system were not fully validated prior to distribution.",
      "root_cause_description": "Software design",
      "action": "A notification letter, dated February 26, 2013, was sent to direct accounts to inform them of the recall and that technicians would visit facilities to replace the Windows 7 operating system with an appropriately validated Windows XP operating system.",
      "product_quantity": "118",
      "distribution_pattern": "Worldwide Distribution: USA (nationwide) and Internationally to: Canada, Slovakia Republic, Sydney and Peru.",
      "openfda": {}
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}