{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "montpellier",
      "state": "",
      "country": "France",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "96967",
      "recalling_firm": "QUANTUM SURGICAL SAS",
      "address_1": "1000 rue du mas de verchant",
      "address_2": "ZAC Eureka",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - U.S. Nationwide distribution in the states of FL,IL, IN, and TX. The countries of France, Germany and United Kingdom.",
      "recall_number": "Z-1927-2025",
      "product_description": "EPIONE Model 30-0001  UDI-DI code: 03760305400031    The EPIONE¿ device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous ablation  procedures in the abdomen, performed by physicians trained for CT procedures and performed under general anaesthesia with rigid straight instruments such as needles and probes of diameters ranging from 11G to 19G.",
      "product_quantity": "4 units in U.S.",
      "reason_for_recall": "Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.",
      "recall_initiation_date": "20250523",
      "center_classification_date": "20250609",
      "report_date": "20250618",
      "code_info": "Model Number: 30-0001 UDI-DI code: 03760305400031 Software Version: 1.0.6.1 Serial Numbers (U.S.): 0322002, 0323006, 0323003 and 0324001",
      "more_code_info": ""
    }
  ]
}