{
  "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,
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  "results": [
    {
      "cfres_id": "203289",
      "product_res_number": "Z-0156-2024",
      "event_date_initiated": "2023-02-28",
      "event_date_posted": "2023-10-24",
      "recall_status": "Open, Classified",
      "res_event_number": "93018",
      "product_code": "IWE",
      "product_description": "Omega Medical Imaging Elevating Monitor Suspension, 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",
      "reason_for_recall": "An actuator separated from the pivot mechanism on a lower monitor boom system column and became detached and was restrained by the installed safety cable at one location.",
      "root_cause_description": "Device Design",
      "action": "Omega Medical Imaging issued a Field Safety Advisory Notice to its consignees on 02/28/2023 by email.  The notice explained the issue and pledged to evaluate all potentially impacted devices and mitigate the issue to bring the boom systems up to the latest safety design and standard of the newer models approved for field use.",
      "product_quantity": "52 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the country of Pakistan.",
      "openfda": {
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        "device_name": "Monitor, Patient Position, Light-Beam",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.5780",
        "device_class": "1"
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    }
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}