{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "115406",
      "product_res_number": "Z-0704-2013",
      "event_date_initiated": "2012-09-26",
      "event_date_posted": "2013-02-27",
      "recall_status": "Terminated",
      "event_date_terminated": "2013-12-05",
      "res_event_number": "64134",
      "product_code": "JAC",
      "product_description": "GE Healthcare Definium 5000/5220493-2  X-Ray System",
      "code_info": "Definium  Model 5000/5220493-2",
      "firm_fei_number": "2126677",
      "recalling_firm": "GE Healthcare, LLC",
      "address_1": "3000 N Grandview Blvd",
      "city": "Waukesha",
      "state": "WI",
      "postal_code": "53188-1615",
      "additional_info_contact": "262-513-4122",
      "reason_for_recall": "When quickly switching the protocols from AEC to Fixed under the same view, if the user selection process time is less than 0.5 seconds, the User Interface (UI) may display different exposure techniques than selected, and may not display AEC setting.  The exposure can still be made as commanded, however it may not be properly indicated.",
      "root_cause_description": "Software design",
      "action": "GE Healthcare will remedy the issue or bring the product into compliance with each applicable Federal standard. A GE Healthcare Service Representative will update the software on the system to address the issue.\n\nCall Center phone number: 800-437-1171 (United States). For other countries, please contact your local GE Healthcare Service Representative if you have any questions or concerns regarding this notification.\n\nPlease be assured that maintaining a high level of safety and quality is our highest priority. If you have any questions, please contact us immediately per the contact information above.",
      "product_quantity": "312 installed in US",
      "distribution_pattern": "Nationwide Distribution",
      "openfda": {
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        "device_name": "System, X-Ray, Film Marking, Radiographic",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.1640",
        "device_class": "1"
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}