{
  "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": "2026-08-13",
    "results": {
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  "results": [
    {
      "cfres_id": "160811",
      "product_res_number": "Z-0385-2018",
      "event_date_initiated": "2017-07-14",
      "event_date_posted": "2018-01-17",
      "recall_status": "Terminated",
      "event_date_terminated": "2018-07-20",
      "res_event_number": "78891",
      "product_code": "MUE",
      "k_numbers": [
        "K121674"
      ],
      "product_description": "Aspire HD Plus (FDR MS-2500), also known as Aspire HD Plus F  and Aspire HD-s (FDR MS-2000),\n also known as Aspire HD Plus S).  Mammography machine\n\nThe 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.",
      "code_info": "FDR MS-2500 made in Japan : S/N- 16640001 or later  FDR MS-2500 made in China : S/N- 26860001 or later  FDR MS-2000 made in Japan : S/N- 16650001 or later  FDR MS-2000 made in China :  S/N- 26870001 or later",
      "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",
      "additional_info_contact": "Randy Vader\n360-356-6821",
      "reason_for_recall": "There was a case that the swivel arm went down unintentionally when it was moved up/down.",
      "root_cause_description": "Employee error",
      "action": "FUJIFILM sent  an Urgent: Medical Device Correction Letter dated July 14, 2017, accompanied by a Customer Feedback form to customers.\n\nPLEASE READ AND FOLLOW THE INSTRUCTIONS\n\nPlease refer to the following page which provides the details of the problem and instructions for actions to be taken. Please follow the instructions in the ACTIONS TO BE TAKEN BY CUSTOMER/USER section.\n\nWe sincerely regret the inconvenience that this may cause you. FUJIFILM is committed to providing products and services of the highest quality. Your satisfaction with FUJIFILM products and with our response to this issue is very important to us.\n\nIf you have any questions about this matter, please contact your local FUJIFILM office. For further questions, please call (360) 356-6821.",
      "product_quantity": "20 US",
      "distribution_pattern": "US Distribution and Internationally to Mexico.",
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        "device_name": "Full Field Digital, System, X-Ray, Mammographic",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.1715",
        "device_class": "2"
      }
    }
  ]
}