{
  "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": "131347",
      "product_res_number": "Z-0523-2015",
      "event_date_initiated": "2014-10-28",
      "event_date_posted": "2014-12-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-07-20",
      "res_event_number": "69686",
      "product_code": "MUE",
      "k_numbers": [
        "K122286"
      ],
      "product_description": "Mammomat Inspiration system: \n\nProduct Usage:  mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by  either hard copy film or soft copy workstation.",
      "code_info": "model number: 10140000",
      "firm_fei_number": "2240869",
      "recalling_firm": "Siemens Medical Solutions USA, Inc",
      "address_1": "51 Valley Stream Pkwy",
      "city": "Malvern",
      "state": "PA",
      "postal_code": "19355",
      "additional_info_contact": "Customer Support\n610-219-6300",
      "reason_for_recall": "It was determined that if the Mammomat Inspiration system is not secured to the floor (per customer request) and monitors are positioned too far from the table top, there is a potential risk that the Acquisition Workstation (AWS) table may become unstable and fall over. This may result in a serious injury to the operator.",
      "root_cause_description": "Use error",
      "action": "A safety advisory notice, dated October 28, 2014, was sent to users that identified the product, problem, and actions to be taken to prevent risk to patients and users. Siemens technicians werre instructed to contact customers to schedule a field modification.",
      "product_quantity": "3",
      "distribution_pattern": "US Nationwide Distribution in the state of: WV, NY, and FL..",
      "openfda": {
        "k_number": [
          "K172404",
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        ],
        "pma_number": [
          "P050014",
          "P030010",
          "P010025",
          "P080018",
          "P010017",
          "P990066"
        ],
        "registration_number": [
          "3009048384",
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        "fei_number": [
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          "3012127758",
          "3023003446",
          "1317307",
          "3002807317",
          "3005877899"
        ],
        "device_name": "Full Field Digital, System, X-Ray, Mammographic",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.1715",
        "device_class": "2"
      }
    }
  ]
}