{
  "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": "Ongoing",
      "city": "St Martin D Heres",
      "state": "N/A",
      "country": "France",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85258",
      "recalling_firm": "Imactis",
      "address_1": "20 Rue Du Tour De L Eau",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Nationwide distribution including in the states of FL & WI.",
      "recall_number": "Z-2972-2020",
      "product_description": "Imactis Patient Fiducial  (Patient Referential), REF: IHR-YY-XXX component   used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)",
      "product_quantity": "6 Navigation Systems",
      "reason_for_recall": "The firm has received reports concerning the patient fiducial disk separating from the body and users attempting  to re-assemble the device.  The use of a  re-assembled patient fiducial could lead to inability to navigate or inaccuracies such as improper needle trajectory.",
      "recall_initiation_date": "20200824",
      "center_classification_date": "20200915",
      "report_date": "20200923",
      "code_info": "All Serial Numbers"
    }
  ]
}