{
  "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": "115627",
      "product_res_number": "Z-0761-2013",
      "event_date_initiated": "2012-08-03",
      "event_date_posted": "2013-02-26",
      "recall_status": "Terminated",
      "event_date_terminated": "2013-12-05",
      "res_event_number": "64226",
      "product_code": "JAC",
      "product_description": "GE Healthcare Brivo XR385 DR-F/ X-Ray System\n\nX-Ray System",
      "code_info": "Model Number : 5271997",
      "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": "GE Healthcare has become aware of a software issue on the interface of the Brivo XR385 DR-F/ Model 5271997 radiographic product related to Visual indication as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-1-3.",
      "root_cause_description": "Radiation Control for Health and Safety Act",
      "action": "GE Healthcare will, without charge, remedy the issue or bring the product into\ncompliance with each applicable Federal and IEC standard in accordance with a planto be approved by the Secretary of Health and Human Services, the details of which will be included in a subsequent communication to you or through a GE Healthcare field engineer site visit. A GE Healthcare Service Representative will update the software on the system to address the issue.\n\nContact Call 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",
      "product_quantity": "9 units installed in US",
      "distribution_pattern": "Nationwide Distribution including NM, WY, FL, MO, MA, and MI.",
      "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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}