{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Paris",
      "state": "N/A",
      "country": "France",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "87505",
      "recalling_firm": "EOS Imaging",
      "address_1": "4 Ieme Etage",
      "address_2": "10 Rue Mercoeur",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed nationwide to MN, OH and internationally to Australia, Canada, Germany, Spain, and France",
      "recall_number": "Z-1415-2021",
      "product_description": "The EOSedge system may acquire two simultaneous orthogonal planar images for a standing or seated patient at low dose. The scan length is defined by the user and may cover the whole body or a specific area (spine, lower limbs, etc.). EOSedge consists of a gantry and an acquisition workstation.  ¿ The gantry contains two orthogonal acquisition units, each of which comprises an X-ray source (high frequency  generator + X-ray tube + collimator) and an X-ray detection system (detector + electronics).  ¿ The acquisition workstation and its software control the generators and detectors. It is also used to enter patient data,  via RIS/HIS or manually, to define acquisition parameters, process images and record images in DICOM 3.0 format.  The intended use/indications for use, technological characteristics, and principles of operation of the EOSedge system are described below.",
      "product_quantity": "11 devices",
      "reason_for_recall": "Inadequate images resizing and 2D measurement errors may occur when biplanar acquisition has been performed with patient orientation different from AP (Antero-Posterior).",
      "recall_initiation_date": "20201222",
      "center_classification_date": "20210412",
      "termination_date": "20230505",
      "report_date": "20210421",
      "code_info": "Product Reference:03663999000108; Serial Numbers: 8.1912.1008, 8.2001.1010, 8.2001.1011, 8.2002.1012, 8.1907.1005, 8.1909.1006, 8.2005.1014, 8.1905.1004, 8.1911.1007, 8.1912.1009, and 8.2006.1016"
    }
  ]
}