{
  "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": "2026-08-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "217584",
      "product_res_number": "Z-0875-2026",
      "event_date_initiated": "2025-10-24",
      "event_date_posted": "2025-12-09",
      "recall_status": "Open, Classified",
      "res_event_number": "98081",
      "product_code": "MUE",
      "k_numbers": [
        "K162268",
        "K173576",
        "K182951"
      ],
      "product_description": "Senographe Pristina, Pristina Serena, and Pristina Serena 3D.  for screening and diagnostic mammography",
      "code_info": "GTINs: 00840682118460, 00840682142052, 00840682145879,\n00195278022745, 00195278276971, 00195278661999, 00195278665379,\n00195278914026",
      "firm_fei_number": "2126677",
      "recalling_firm": "GE Medical Systems, LLC",
      "address_1": "3000 N Grandview Blvd",
      "city": "Waukesha",
      "state": "WI",
      "postal_code": "53188-1615",
      "additional_info_contact": "262-544-3011",
      "reason_for_recall": "Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR 1020.30(j).",
      "root_cause_description": "Radiation Control for Health and Safety Act",
      "action": "GE Healthcare notified sent customers notification letter dated October 24, 2025 and instructed in the letter, the customer will inspect and identify systems that have a\nmissing or incorrect label.",
      "product_quantity": "1,818 (1,580 US; 238 OUS)",
      "distribution_pattern": "U.S. and OUS.",
      "openfda": {
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        ],
        "pma_number": [
          "P010025",
          "P050014",
          "P080018",
          "P030010",
          "P990066",
          "P010017"
        ],
        "registration_number": [
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        ],
        "device_name": "Full Field Digital, System, X-Ray, Mammographic",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.1715",
        "device_class": "2"
      }
    }
  ]
}