{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "203492",
      "product_res_number": "Z-0160-2024",
      "event_date_initiated": "2023-09-08",
      "event_date_posted": "2023-10-24",
      "recall_status": "Open, Classified",
      "res_event_number": "93123",
      "product_code": "IWE",
      "product_description": "Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085",
      "code_info": "all units manufactured between 10-22-2012 and 07-09-2019",
      "firm_fei_number": "1000222289",
      "recalling_firm": "Omega Medical Imaging, Inc.",
      "address_1": "3400 Saint Johns Pkwy Ste 1020",
      "city": "Sanford",
      "state": "FL",
      "postal_code": "32771-6769",
      "additional_info_contact": "Mr. Brian Fleming\n407-323-9400",
      "reason_for_recall": "An actuator separated from the pivot mechanism on a lower monitor boom system column. The lower boom became detached at the point shown and was restrained by the installed safety cable.",
      "root_cause_description": "Device Design",
      "action": "Omega Medical Imaging issued a Field Safety Advisory Notice to its consignees on 09/08/2023 via email.  The notice explained the problem and the risk.  The firm will inspect all affected devices to ensure the proper fasteners were installed on the unit.",
      "product_quantity": "31 units",
      "distribution_pattern": "Alabama, California, Illinois, Indiana, Kentucky, Louisiana, Missouri, Montana, North Carolina, Ohio, Oklahoma",
      "openfda": {
        "k_number": [
          "K930295",
          "K904753",
          "K955236",
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          "K872489",
          "K893398",
          "K951601",
          "K152303",
          "K973162",
          "K950293",
          "K954414"
        ],
        "registration_number": [
          "2029275",
          "1055485",
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          "3000253133",
          "3017956012",
          "3003768251",
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          "3027645317",
          "3007615597"
        ],
        "device_name": "Monitor, Patient Position, Light-Beam",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.5780",
        "device_class": "1"
      }
    }
  ]
}