{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "68347",
      "product_res_number": "Z-0842-2008",
      "event_date_initiated": "2007-11-01",
      "event_date_posted": "2008-06-10",
      "recall_status": "Terminated",
      "event_date_terminated": "2011-12-18",
      "res_event_number": "46859",
      "product_code": "KPR",
      "k_numbers": [
        "K993090"
      ],
      "product_description": "GE Healthcare Proteus XR/a Radiographic X-ray System, Model Number 2259976; previously marketed as the Silhouette FC, GE Healthcare, Waukesha, WI 53188.",
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      "firm_fei_number": "2126677",
      "recalling_firm": "GE Healthcare",
      "address_1": "3000 N Grandview Blvd",
      "city": "Waukesha",
      "state": "WI",
      "postal_code": "53188-1615",
      "additional_info_contact": "262-544-3894",
      "reason_for_recall": "The warning label that is required by 21 CFR 1020.30(j) was not on the control console of the Proteus XR/a Radiographic X-ray System, Model 2259976.",
      "root_cause_description": "Process control",
      "action": "GE issued a Field Modification Instruction to their field service representatives, released in December 2007, with instructions to replace the labels on the console with the appropriate labeling.  Consignees will be visited by GE field service representatives beginning December 2007.  All consignees will have the required labels affixed to their units by July 31, 2008.",
      "product_quantity": "400 Units",
      "distribution_pattern": "Worldwide Distribution, including USA, Canada, Mexico, France, Hong Kong, Italy, Korea, China, Poland, UK, New Zealand, Saudi Arabia, Taiwan, Turkey, and Australia.",
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        "medical_specialty_description": "Radiology",
        "regulation_number": "892.1680",
        "device_class": "2"
      }
    }
  ]
}