{
  "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": "114302",
      "product_res_number": "Z-0198-2013",
      "event_date_initiated": "2012-09-20",
      "event_date_posted": "2012-11-16",
      "recall_status": "Terminated",
      "event_date_terminated": "2013-12-05",
      "res_event_number": "63597",
      "product_code": "OXO",
      "product_description": "GE Healthcare Optima XR 220amx\n\nMobile general purpose radiographic imaging of the human head and body.",
      "code_info": "part numbers:  5555000-5, 5555000-6",
      "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": "It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54.",
      "root_cause_description": "Radiation Control for Health and Safety Act",
      "action": "GE Healthcare will remedy the defect or bring the product into compliance with each applicable Federal and IEC standard. A Service Representative will update the firmware on the system to address the issue.\n\nField Modification Instructions (FMI) 10870, 10872, and 10873 are describing the rework plan the GEHC Engineers will make to the imaging systems compliant with the applicable performance standard.\n\nFurther questions please call  (262) 513-4122.",
      "product_quantity": "364 total units installed in US",
      "distribution_pattern": "Nationwide Distribution",
      "openfda": {
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        "device_name": "Image-Intensified Fluoroscopic X-Ray System, Mobile",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.1650",
        "device_class": "2"
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}