{
  "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": "161290",
      "product_res_number": "Z-0659-2018",
      "event_date_initiated": "2017-08-04",
      "event_date_created": "2018-02-20",
      "recall_status": "Terminated",
      "event_date_terminated": "2019-04-01",
      "res_event_number": "79078",
      "product_code": "MUE",
      "k_numbers": [
        "K110729"
      ],
      "product_description": "Aspire HD (for FDR-1000AWS)\n\nThe Fujifilm Digital Mammography System, Aspire HD (FDR MS-l000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.",
      "code_info": "1000AWS.\tReleased Software Versions: V5.0, V5.1. Not Released Software Versions:\tV5.2, V6.0, V6.1, V7.0.",
      "firm_fei_number": "1000513161",
      "recalling_firm": "Fujifilm Medical Systems U.S.A., Inc.",
      "address_1": "419 West Ave",
      "city": "Stamford",
      "state": "CT",
      "postal_code": "06902-6343",
      "reason_for_recall": "FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system.\nThe acquisition workstations, FDR1000AWS, FDR-2000AWS, FDR-3000AWS, and CRIR363AWS assign a\nunique ID number to every image study but very rarely, with the acquisition workstation software versions,\nVS.O, VS.1, VS.2 , V6.0, V6.1, and V7.0, the system may assign the same ID number to a new set of images\nthat was already assigned to the previous set of images due to the error in ID number generation logic. If an\nImage with this error (with duplicate ID number) Is transmitted to PACS, it may overwrite the image already\nstored on PACS.",
      "root_cause_description": "Software design",
      "action": "The firm, FUJIFILM Medical Systems U.S.A., Inc. (FMSU), sent an \"URGENT: MEDICAL DEVICE CORRECTION\" letter dated 7/28/2017 to its customers. The letter described the products, problem and actions to be taken. The customers were instructed to please read and follow the instructions in the \"ACTIONS TO BE TAKEN BY CUSTOMER/USER\" section. If you have an error, contact your local FUJIFILM office; and complete and return the Customer Feedback Form.\n\nFUJIFILM service personnel will contact all of the medical facilities where the applicable products have been installed to arrange for this correction and visit to take corrective measures..\n\nIf you have any questions about this matter, call Recall contact (203) 276-3445 or email: dharaben.desai@fujifilm.com.",
      "product_quantity": "71 units (68 units Domestic. 3 units Foreign) in total",
      "distribution_pattern": "Worldwide Distribution.",
      "openfda": {
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          "K172404",
          "K260087",
          "K211725",
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          "K192317",
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          "K200424",
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          "K110717",
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          "K151645",
          "K111361",
          "K110729",
          "K130704",
          "K172027",
          "K173576",
          "K163328",
          "K190809",
          "K163252",
          "K122510",
          "K212873",
          "K111324",
          "K162670",
          "K170930",
          "K202822",
          "K111646",
          "K122286",
          "K163302"
        ],
        "pma_number": [
          "P050014",
          "P030010",
          "P010025",
          "P080018",
          "P010017",
          "P990066"
        ],
        "registration_number": [
          "3009048384",
          "3008833258",
          "3005406110",
          "3005496266",
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          "9611343",
          "9680027",
          "3012127758",
          "3023003446",
          "1317307",
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        ],
        "fei_number": [
          "3009048384",
          "3008833258",
          "3005406110",
          "3005496266",
          "3010703925",
          "1000514697",
          "3001722928",
          "3017585294",
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          "3015276088",
          "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"
      }
    }
  ]
}