{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "204983",
      "product_res_number": "Z-0789-2024",
      "event_date_initiated": "2023-10-30",
      "event_date_posted": "2024-01-25",
      "recall_status": "Open, Classified",
      "res_event_number": "93624",
      "product_code": "MUD",
      "k_numbers": [
        "K201976"
      ],
      "product_description": "Snapshot NIR, REF: KD204",
      "code_info": "UDI-DI: B376KD2040, Serial Numbers: 204TUC1001, 204TUC1002, 204TUC1003, 204TUC1004, 7204TUC1005, 204TUC1006, 204TUC1007, 204TUC1008, 204TUC1009, 204TUC1010, 204TUC1011, 204TUC1012, 204TUC1013, 204TUC1014, 204TUC1015, 204TUC1024, 204TUC1025, 204TUC1026, 204TUC1028, 204TUC1029, 204TUC1033, 204TUC1036, 204TUC1038, 204TUC1040, 204TUC1041, 204TUC1042,  204TUC1043",
      "firm_fei_number": "3009771004",
      "recalling_firm": "KENT IMAGING, INC.",
      "address_1": "Suite 300, 1210 8 Street SW 1210 8 Street SW",
      "address_2": "Suite 300",
      "city": "Calgary",
      "country": "Canada",
      "reason_for_recall": "Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "On 10/30/23, recall notices were mailed and emailed to customers who were asked to do the following:\n\nCustomers are asked to choose two ways to obtain replacement devices.  Either the firm will ship replacement devices to customers and customers will ship affected devices back to the firm, or 2) Firm personnel will exchange devices through visit.\n\nCustomer with questions can contact the firm via phone,  1-403-455-7610, or via their website, https://www.kentimaging.com/contact",
      "product_quantity": "57",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of IN, OH, TX, PA, WI, OR, CO, IL, MO, CA, AZ, IA and the countries of Malaysia.",
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        "device_name": "Oximeter, Tissue Saturation",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.2700",
        "device_class": "2"
      }
    }
  ]
}