{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "194323",
      "product_res_number": "Z-1309-2022",
      "event_date_initiated": "2022-06-02",
      "event_date_created": "2022-06-30",
      "recall_status": "Open, Classified",
      "res_event_number": "90400",
      "product_code": "FQO",
      "product_description": "Product Name: GCX Channel Mounting Accessory\nModel/Catalog Number: H8-300-40-A",
      "code_info": "Lot Code: All units of model H8-300-40-A are affected.\nCode Info: GCX mounting bracket does not have UDI.\nErgon 3 booms after September 2016 have UDI. DI of units manufactured after September 2016 is 10841736100889. Units manufactured prior to September 2016 do not have UDI.",
      "firm_fei_number": "1825014",
      "recalling_firm": "Skytron, Div. The KMW Group, Inc",
      "address_1": "5085 Corporate Exchange Blvd SE",
      "city": "Grand Rapids",
      "state": "MI",
      "postal_code": "49512-5515",
      "reason_for_recall": "Under certain circumstances, the mounting screws may loosen or pull out from the attachment point on the Ergon 3 boom when the GCX Channel Mounting Accessory was used with the VST clamp as a monitor mount on the boom.",
      "root_cause_description": "Component design/selection",
      "action": "On June 2, 2022, the firm sent out Urgent Medical Device Correction letters to affected customers. Customers were instructed to identify their GCX Channel Mounting Accessories used with Ergon 3 booms. Customers should inspect their mounting accessories. If the user sees that the channel is tilted on the VST clamp, this could indicate that the screws or tension knob have loosened. Remove the device from service if you find evidence that it may fail.\n\nSkytron authorized representatives will contact customers to schedule a service visit.\n\nPlease contact quality at quality@skytron.com with any questions.",
      "product_quantity": "731",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada and Japan.",
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        "device_name": "Table, Operating-Room, Ac-Powered",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4960",
        "device_class": "1"
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    }
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}