{
  "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": "78891",
      "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": "US Distribution and Internationally to Mexico.",
      "recall_number": "Z-0386-2018",
      "product_description": "ASPIRE Cristalle (FDR MS-3500)  Mammography machine    The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems.",
      "product_quantity": "15 US 1 OUS",
      "reason_for_recall": "There was a case that the swivel arm went down unintentionally when it was moved up/down.",
      "recall_initiation_date": "20170714",
      "center_classification_date": "20180118",
      "termination_date": "20180720",
      "report_date": "20180124",
      "code_info": "FDR MS-3500 : S/N- 76221095 or earlier"
    }
  ]
}