{
  "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": "217161",
      "product_res_number": "Z-0879-2026",
      "event_date_initiated": "2025-10-24",
      "event_date_posted": "2025-12-03",
      "recall_status": "Open, Classified",
      "res_event_number": "97920",
      "product_code": "MUE",
      "k_numbers": [
        "K151645"
      ],
      "product_description": "MAMMOMAT Fusion;",
      "code_info": "Model Number: 10140000;\nUDI-DI: 04056869009063;\nSystem Serial Numbers: 10559;",
      "firm_fei_number": "2240869",
      "recalling_firm": "Siemens Medical Solutions USA, Inc",
      "address_1": "40 Liberty Blvd",
      "city": "Malvern",
      "state": "PA",
      "postal_code": "19355-1418",
      "additional_info_contact": "Rebecca Tudor\n610-219-4834",
      "reason_for_recall": "There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.",
      "root_cause_description": "Component design/selection",
      "action": "On October 24, 2025 URGENT: MEDICAL DEVICE CORRECTION letters were sent to customers.  Actions to be taken: Please ensure that all users of the affected products within your organization and others who may need to be\ninformed will receive the relevant safety information provided within this notice and will comply with the\nrecommendations therein.\nWe appreciate your understanding and cooperation with this safety advisory and ask you to immediately\ninstruct your personnel accordingly. Please ensure that this safety advisory is retained in your product related\nrecords appropriately. Please keep this information until the corrective measures have been finalized. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this\nCustomer Safety Advisory Notice. Please respond within 14 days of receiving this notification. If this device/equipment is no longer in your possession, please forward this Customer Safety Advisory Notice\nto the new owner of this device. If applicable, please inform us about the new owner of the device.",
      "product_quantity": "1 unit (OUS only)",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of AR, CA, NY and the countries of  Australia, Canada, India.",
      "openfda": {
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          "K122286",
          "K163302"
        ],
        "pma_number": [
          "P050014",
          "P030010",
          "P010025",
          "P080018",
          "P010017",
          "P990066"
        ],
        "registration_number": [
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          "9611343",
          "9680027",
          "3012127758",
          "3023003446",
          "1317307",
          "3005877899"
        ],
        "fei_number": [
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          "3008833258",
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          "3005496266",
          "3010703925",
          "1000514697",
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          "3012127758",
          "3023003446",
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          "3002807317",
          "3005877899"
        ],
        "device_name": "Full Field Digital, System, X-Ray, Mammographic",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.1715",
        "device_class": "2"
      }
    }
  ]
}