{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Stamford",
      "state": "CT",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "79078",
      "recalling_firm": "Fujifilm Medical Systems U.S.A., Inc.",
      "address_1": "419 West Ave",
      "address_2": "N/A",
      "postal_code": "06902-6343",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution.",
      "recall_number": "Z-0661-2018",
      "product_description": "ASPIRE Cristalle (for FDR-3000AWS)     The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500) 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.",
      "product_quantity": "71 units (68 units Domestic. 3 units Foreign) in total",
      "reason_for_recall": "FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system.  The acquisition workstations, FDR¿1000AWS, FDR-2000AWS, FDR-3000AWS, and CR¿IR363AWS assign a  unique ID number to every image study but very rarely, with the acquisition workstation software versions,  VS.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  that was already assigned to the previous set of images due to the error in ID number generation logic. If an  Image with this error (with duplicate ID number) Is transmitted to PACS, it may overwrite the image already  stored on PACS.",
      "recall_initiation_date": "20170804",
      "center_classification_date": "20180220",
      "termination_date": "20190401",
      "report_date": "20180228",
      "code_info": "3000AWS. Released Software Versions: V5.1, V5.2, V6.0, V6.1, V7.0. Not Released Software Versions: V5.0."
    }
  ]
}